EVIDENCE-BASED RESOURCE GUIDE SERIES

Prevention and 

Treatment of HIV 

Among People Living 

with Substance 

Use and/or Mental 

Disorders
II

Prevention and Treatment of HIV Among 

People Living with Substance Use and/or 

Mental Disorders

Acknowledgments

This report was prepared for the Substance Abuse and Mental Health Services Administration (SAMHSA), 

U.S. Department of Health and Human Services (HHS), under contract number HHSS283201700001/ 

75S20319F42002 with SAMHSA, HHS. Donelle Johnson served as contracting officer representative.

Disclaimer

The views, opinions, and content of this publication are those of the authors and do not necessarily reflect 

the views, opinions, or policies of SAMHSA. Nothing in this document constitutes a direct or indirect 

endorsement by SAMHSA of any non-federal entity’s products, services, or policies, and any reference to nonfederal entity’s products, services, or policies should not be construed as such.

Public Domain Notice

All material appearing in this publication is in the public domain and may be reproduced or copied without 

permission from SAMHSA. Citation of the source is appreciated. However, this publication may not be 

reproduced or distributed for a fee without the specific, written authorization of the Office of Communications, 

SAMHSA, HHS.

Electronic Access

This publication may be downloaded from http://store.samhsa.gov

Recommended Citation

Substance Abuse and Mental Health Services Administration (SAMHSA). Prevention and Treatment of 

HIV Among People Living with Substance Use and/or Mental Disorders. Publication No. PEP20-06-03-001 

Rockville, MD: National Mental Health and Substance Use Policy Laboratory. Substance Abuse and Mental 

Health Services Administration, 2020.

Originating Office

National Mental Health and Substance Use Policy Laboratory, Substance Abuse and Mental Health Services 

Administration, 5600 Fishers Lane, Rockville, MD 20857, Publication No. PEP20-06-03-001. Released 2020.

Nondiscrimination Notice

SAMHSA complies with applicable federal civil rights laws and does not discriminate on the basis of race, 

color, national origin, age, disability, or sex.

SAMHSA cumple con las leyes federales de derechos civiles aplicables y no discrimina por motivos de raza, 

color, nacionalidad, ni edad.

Publication No. PEP20-06-03-001

Released 2020

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Acknowledgments 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Message from Assistant Secretary for Mental Health and Substance Use III

MESSAGE FROM THE ASSISTANT SECRETARY

FOR MENTAL HEALTH AND SUBSTANCE USE, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

As the first U.S. Department of Health and Human Services Assistant Secretary for Mental Health and 

Substance Use at the Substance Abuse and Mental Health Services Administration (SAMHSA), I am pleased to 

present this new resource: Prevention and Treatment of HIV Among People Living with Substance Use and/or 

Mental Disorders.

In response to the charge of the 21st Century Cures Act to disseminate information on evidence-based practices 

and service delivery models, the National Mental Health and Substance Use Policy Laboratory has developed 

the Evidence-Based Resource Guide Series focused on the prevention and treatment of substance use disorders 

(SUD) and mental illnesses. With this specific guide, SAMHSA’s goal is to inform health care practitioners 

and administrators, policy makers, and community members about strategies to prevent and treat HIV among 

individuals who have mental illness and/or SUD. 

Established in 2019, the federal initiative “Ending the HIV Epidemic: A Plan for America” aims to reduce 

new HIV infections in the United States by 90 percent by the year 2030. It encourages implementation of HIV 

prevention, diagnosis, treatment, and outbreak response through effective programs, practices, and resources. 

Supporting the needs of people at risk for and with HIV who have co-occurring mental illness and/or SUD is key 

to meeting the initiative’s goals. People with mental illness and/or SUD are particularly vulnerable to HIV. SUD, 

in particular, can hasten the progress of HIV.1

 More specifically, injection drug use increases the risk of getting or 

transmitting the disease,2

 and the risk of getting HIV is 4 to 10 times greater for people with mental illness.3

This guide reviews effective programs and practices to prevent HIV and increase adherence to and retention in 

care. I encourage you to use this guide to become informed about the populations experiencing mental illness and/

or SUD with or at risk for HIV; to review the current evidence on the effectiveness of programs and practices to 

prevent HIV among this population; and to develop and implement appropriate and effective programming in your 

communities. Ultimately, your efforts will help meet the goals of ending the HIV epidemic over the next decade.

Elinore F. McCance-Katz, MD, PhD

Assistant Secretary for Mental Health and Substance Use

U.S. Department of Health and Human Services

1 National Institute on Drug Abuse. (2020, April 10). Common comorbidities with substance use disorders research report. https://

www.drugabuse.gov/publications/research-reports/common-comorbidities-substance-use-disorders/part-3-connection-betweensubstance-use-disorders-hiv

2 National Institute on Drug Abuse. (2020, April 10). ibid

3 Remien, R. H., Stirratt, M. K., Nguyen, N., Robbins, R. N., Pala, A. N., & Mellins, C. A. (2019). Mental health and HIV/AIDS: The 

need for an integrated response. AIDS, 33(9), 1411-1420. doi: 10.1097/QAD.0000000000002227 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Evidence-Based Resource Guide Series Overview IV

FOREWORD

Evidence-Based Resource Guide 

Series Overview

The Substance Abuse and Mental Health Services 

Administration (SAMHSA), and specifically, the 

National Mental Health and Substance Use Policy 

Laboratory (Policy Lab), is pleased to fulfill the charge 

of the 21st Century Cures Act to disseminate information 

on evidence-based practices and service delivery models 

to prevent substance misuse and help people with 

substance use disorders (SUD), serious mental illnesses 

(SMI), and serious emotional disturbances (SED) get the 

treatment and support they need.

Treatment and recovery for SUD, SMI, and SED can 

vary based on a number of geographic, socio-economic, 

cultural, gender, race, ethnicity, and age-related factors, 

which can complicate evaluating the effectiveness 

of services, treatments, and supports. Despite these 

variations, however, there is substantial evidence to 

inform the types of resources that can help reduce 

substance use, lessen symptoms of mental illness, and 

improve quality of life. 

This Evidence-Based Resource Guide Series contains 

a comprehensive set of modules with information 

to improve health outcomes for people at risk for 

developing, living with, or recovering from mental 

illness and/or SUD. It is designed for practitioners, 

administrators, community leaders, and others 

considering an intervention for their organization or 

community.

A priority topic for SAMHSA is preventing human 

immunodeficiency virus (HIV) among people with 

mental illness and/or SUD and linking people with 

HIV and co-occurring mental illness and/or SUD to 

HIV care. This guide reviews research findings and 

literature related to this issue, examines emerging and 

best practices, and identifies challenges and strategies for 

implementation.

SAMHSA’s Policy Lab developed this guide between 2019 and 2020, prior to and during the COVID-19 

pandemic. The practices and programs included in Chapter 2 were studied prior to the onset of COVID-19 and 

may require adaptation to accommodate the unique challenges of delivering health care during the pandemic. 

Implementation strategies, outlined in Chapter 3, may also need to account for COVID-19 conditions in each 

community, county, and state. Finally, the practices and programs highlighted in Chapter 4 are examples of 

implementation prior to and at early phases of the pandemic. It is possible these organizations and programs 

have modified their service delivery to include telehealth and other ways of providing services due to the 

COVID-19 public health emergency. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Evidence-Based Resource Guide Series Overview V

Expert panels of federal, state, and non-governmental 

participants provided input for each guide in this series. 

The panels included accomplished scientists, researchers, 

service providers, community administrators, federal and 

state policy makers, and people with lived experience. 

Members provided input based on their knowledge of 

healthcare systems, implementation strategies, evidencebased practices, provision of services, and policies that 

foster change.

Research shows that implementing evidence-based 

practices requires a comprehensive, multi-pronged 

approach. This guide is one piece of an overall approach 

to implement and sustain change. Readers are encouraged 

to visit the SAMHSA website for additional tools and 

technical assistance opportunities.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Evidence-Based Resource Guide Series Overview VI

Content of the Guide

This guide contains a foreword and five chapters. The chapters stand alone and 

can be read in any order. Each chapter is designed to be brief and accessible 

to healthcare practitioners, healthcare system administrators, community 

members, policy makers, and others working to meet the needs of people at risk 

for developing, experiencing, or recovering from mental illness and/or SUD. 

The goal of this guide is to review the literature on preventing and treating 

HIV for people with mental illness and/or SUD, distill the research into 

recommendations for practice, and provide examples of how practitioners use 

these practices in their programs. 1

FW Evidence-Based Resource Guide Series Overview

Introduction to the series.

1 Issue Brief

Overview of current approaches and challenges to preventing 

and treating HIV for people with mental illness and/or SUD. 

2 What Research Tells Us

Current evidence on effectiveness of programs and strategies to 

prevent HIV among people with co-occurring mental illness and/

or SUD and link them to HIV care: Practices to increase uptake 

of and improve adherence to Pre-Exposure Prophylaxis (PrEP), 

Syringe Services Programs, Contingency Management, Cognitive 

Behavioral Therapy, and Patient Navigation. 

3 Guidance for Selecting and Implementing 

Evidence-based Practices

Practical information to consider when selecting and implementing 

programs and practices to improve health outcomes for people 

with mental illness and/or SUD with or at risk for HIV.

4 Examples of Effective Programs and Strategies

Descriptions of programs and practices to prevent HIV and link 

people with HIV and co-occurring mental illness and/or SUD to 

HIV care. 

5 Resources for Evaluation and Quality Improvement

Guidance and resources for implementing best practices, 

monitoring outcomes, and improving quality.

FOCUS OF THE GUIDE

People with mental illness and/or 

SUD are disproportionally affected 

by HIV. They may participate 

in behaviors that increase risk 

for contracting and transmitting 

HIV, such as sharing injection 

drug equipment or engaging in 

sexual behaviors that increase 

HIV risk. This guide addresses 

the co-occurrence of HIV and 

mental illness and/or SUD. It 

reviews effective programs and 

practices to prevent HIV and, for 

those with HIV, to increase linkage 

and retention in care in order to 

improve health outcomes.

A NOTE ON MEDICATIONS FOR 

OPIOID USE DISORDER

SAMHSA has an extensive online resource center with tools for use 

alongside this guide. For example, practitioners can use the current 

(2020) Treatment Improvement Protocol (TIP) 63: Medications for 

Opioid Use Disorder together with practices recommended in this guide 

to support improved health outcomes for people with or at risk for HIV 

who are experiencing opioid use disorder. To avoid duplication, this 

guide does not discuss medications for opioid use disorder.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Evidence-Based Resource Guide Series Overview VII

The framework below provides an overview of this guide. The guide addresses the prevention and treatment of HIV among 

people with mental illness and/or SUD, and focuses on prevention and treatment practices that have been evaluated with 

adults. The review of these programs and practices in Chapter 2 of the guide includes specific outcomes, practitioner types, 

and delivery settings.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 1

1

CHAPTER

Issue Brief

First detected in 1981,1 human immunodeficiency virus 

(HIV) is a retrovirus that infects a type of white blood 

cells called CD4+ T-cells and puts people at increased 

risk for other infections. If left untreated, HIV can lead 

to acquired immunodeficiency syndrome (AIDS), which 

was once a fatal infection. 

While there is no cure for HIV, it can be effectively 

managed as a chronic illness with antiretroviral therapy 

(ART), and prevented through harm reduction strategies 

(e.g., condoms and syringe services programs) and 

medical interventions (e.g., pre-exposure prophylaxis 

[PrEP] and post-exposure prophylaxis [PEP]).

Substantial progress has been made in preventing 

HIV and supporting people with HIV, however, there 

is still room for improvement in addressing linkage 

to treatment, ART initiation and adherence, and viral 

suppression, as well as engagement and retention along 

the HIV care continuum. 

Challenges with client engagement across the HIV 

care continuum hinder the effectiveness of prevention 

and treatment efforts. These challenges increase the 

likelihood of HIV transmission and negative health 

outcomes for people with HIV.

Established in 2019, the federal initiative “Ending the 

HIV Epidemic: A Plan for America” (EHE)4

 capitalizes 

on scientific discoveries and increased public awareness 

to prevent and treat HIV. As of 2020, there are 1 million 

people with HIV in the United States, and an estimated 

38,000 new infections occur each year.5

 The goal of the 

EHE initiative is to reduce new infections by 75 percent 

by 2025 and by 90 percent by 2030.6

The success of the EHE initiative relies on identifying 

pathways to increase access to HIV prevention and 

treatment for those with complex needs.7-8

Biomedical Interventions for HIV Prevention and Treatment

Pre-Exposure Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP) are medications that can be taken to 

prevent HIV transmission. PrEP has been shown to reduce the risk of contracting HIV from sex by 99 percent, and 

contracting HIV from injection drug use by 74 percent.2

 PEP, when taken within three days of possible exposure to 

the virus, has been shown to lower chances of HIV transmission by more than 80 percent.3

ART is a combination of medications used to treat HIV. ART blocks HIV replication, decreasing the amount of HIV 

in blood and bodily fluids. By reducing the HIV viral load (amount of virus) in the body, ART improves the health 

outcomes of people with HIV; decreases mortality; and, when treatment results in an undetectable viral load, 

reduces the chance of transmitting the disease to others to zero. The availability of and adherence to ART has 

changed HIV from a terminal diagnosis to a manageable chronic disease.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 2

HIV Testing

In the United States, about 1 in 7 (14 percent) of the 

estimated 1 million people with HIV do not know they 

have the disease.9

 Testing identifies a person’s HIV 

status and helps to link those who are newly diagnosed 

with HIV to care. Testing also helps to prevent HIV 

transmission and new infections.10 Individuals who are 

undiagnosed or unaware of their HIV infection account 

for an estimated 30 to 40 percent of ongoing HIV 

transmissions.11-12 The U.S. Preventive Services Task 

Force recommends that clinicians conduct screening for 

HIV infection among individuals aged 15 to 65, younger 

adolescents and older adults at increased risk, and all 

pregnant women, giving the recommendation an “A” 

rating, requiring HIV testing be provided free by health 

insurance companies.13-15

The EHE initiative recommends the following steps to 

increase the number of undiagnosed people with HIV 

who receive an HIV test, are diagnosed, and receive 

treatment: 1) make HIV testing simple, accessible, and 

routine in healthcare and non-healthcare settings using 

innovative technology, systems, and programs; and 2) 

conduct focused work to increase annual testing among 

people who are at substantial risk for HIV. HIV testing 

can be conducted in a range of clinical settings or at 

home (through rapid or mail-in self-tests).16-17

Behavioral health providers play an essential role in 

providing integrated HIV, viral hepatitis, mental health, 

and substance use screenings within the clinic setting. 

In a 2019 “Dear Colleague Letter,” SAMHSA called on 

mental health and substance use providers to increase 

on-site, same-day oral fluid HIV testing efforts and 

include HIV testing as part of the standard of care.19

Oral fluid testing can be self-administered and provides 

results within 20 minutes.20 Settings that provide 

screening for many common co-occurring illnesses 

often include testing for viral hepatitis to address both 

hepatitis prevention and potentially serious co-occurring 

HIV and viral hepatitis infections.21

People with any mental illness diagnoses or symptoms 

were more likely to report being tested for HIV than 

those without mental illness diagnoses or symptoms.22
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 3

However, only 48.5 percent of people with a mental 

illness have had an HIV test.23 Once diagnosed with 

HIV, persons with three or more psychosocial concerns 

were less likely to be adherent to HIV medications and 

persons with four or more problems were less likely to 

be virally suppressed.24 People with mental illnesses 

were less likely to be prescribed ART and achieve viral 

suppression.25 

Aligning with the EHE key strategy of diagnosing all 

individuals with HIV, universal testing in behavioral 

health settings can support rapid linkage to preventive 

services and HIV care including supportive services to 

increase PrEP uptake and adherence, syringe services 

programs (SSPs), cognitive behavioral therapy (CBT), 

contingency management (CM), and patient navigation 

(further discussed in Chapter 2).26 The flow diagram (on 

page 4) shows the role of mental health and substance 

use providers in caring for clients who are at risk for or 

have been diagnosed with HIV.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 4

Substance Use and HIV

SUD can increase the risk of getting HIV and negatively 

impact HIV care, treatment, and related health outcomes. 

The prevalence of substance use among people with 

HIV is also higher than among the general population 

(as shown in the chart below). People who inject drugs 

(PWID) are at increased risk for blood borne pathogens, 

such as HIV and hepatitis B and C.27 In 2017, 9 percent 

(or 3,641) of the 38,739 new HIV diagnoses in the 

United States and its territories were among PWID.6, 

28 Of that population, 2,625 were male and 1,016 were 

female.28 Six percent (or 2,389) of new HIV diagnoses 

in the United States were directly attributed to PWID.29

New HIV diagnoses are most prevalent among Whites, 

Blacks/African Americans, and individuals between the 

ages of 25 and 44.28

In addition, research suggests that substance use, 

including alcohol,30-32 methamphetamine,33-34 cocaine,35

opioids, and inhalants, increases sexual behaviors that 

are associated with increased likelihood of getting HIV 

(e.g., condomless sex).28, 36-38

Mental Health and HIV

Mental illness can interfere with HIV prevention and 

adherence to treatment48-49 and is linked to behaviors that 

increase likelihood of getting HIV.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 5

The prevalence of mental illness among people with HIV 

is also higher than among the general population (as shown 

in the chart below). People with HIV may experience 

high rates of depression, mood disorders, and generalized 

anxiety disorder.50-55 An estimated 10 to 28 percent of 

people with HIV have co-occurring mental illness and/or 

SUD.

56 People with HIV who also experience depression 

report higher rates of other co-occurring mental health 

concerns such as anxiety disorders (78 percent) and 

SUD (61 percent), as well as increased viral loads.54, 57-58

Depression in people with HIV can also negatively affect 

HIV treatment, as it is associated with discontinuation of 

and non-adherence to ART.59-60

In addition to depression and anxiety, trauma and posttraumatic stress disorder (PTSD) are strongly associated 

with HIV. Experiences of trauma among people with 

HIV can lead to behavior that increases likelihood of 

transmitting HIV, lower adherence to HIV care and 

ART, and higher likelihood of AIDS-related mortality.61

Among women in the United States with HIV, 30 percent 

have PTSD (five times the national rate for women).62

Substances and HIV-Related Outcomes

Alcohol Heavy alcohol consumption is linked to sexual behaviors that increase likelihood 

of getting HIV and associated with delays in HIV diagnosis and lower rates of ART 

receipt and adherence.39-40

Opioids Opioid use is associated with injection drug use equipment sharing and sexual 

behaviors that increase likelihood of getting HIV.41-42 Injection drug use presents 

increased likelihood for HIV transmission, because the virus can survive in a used 

syringe for up to 42 days. A person without HIV has a 1 in 160 chance of getting HIV 

when using a syringe previously used by someone who has HIV.38 Emerging evidence 

suggests that individuals who misuse prescription opioids are engaging in sexual 

behaviors that increase likelihood of getting HIV (e.g., condomless sex, sex with 

multiple partners).42-43

Methamphetamine Methamphetamine use is associated with injection drug use equipment sharing 

and sexual behaviors that increase likelihood of getting HIV. People who actively 

use methamphetamines have lower rates of adherence to ART and medical followup (impacting both prevention and treatment).44-45

“Club drugs” [e.g., 3,4- 

methylenedioxymethamphetamine 

(MDMA, Ecstasy, Molly), 

Ketamine (Special K), Gamma 

Hydroxybutyric Acid (GHB, Liquid 

Ecstasy), alkyl nitrites (Poppers, 

TNT)]46

“Club drugs” have been linked to sexual behaviors that increase likelihood of 

getting HIV. However, studies on these drugs are complicated, as it can be difficult 

to determine the timing of drug use and sexual behavior. Poly-drug use is also 

common among users of club drugs, complicating analyses.47
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 6

Furthermore, women from low-income, high-HIV 

prevalence communities experience stressors that lead 

to the development of PTSD, such as high rates of child 

maltreatment and physical, emotional, and sexual abuse.63

Interrelated Factors that Impact HIV Prevention 

and Treatment Efforts

Understanding the complex relationship between social 

determinants of health, unmet needs, and HIV-related risk 

factors is key to addressing HIV and mental illness and/

or SUD.

64 For example, it is difficult to engage people in 

HIV prevention or treatment programs when their basic 

ancillary needs (e.g., housing, child care, transportation, 

food, employment, health insurance) are not met.65-68 In 

urban, high-poverty areas, higher HIV prevalence tends 

to be associated with socioeconomic status, including 

educational attainment, household income, employment 

status, structural racism, and housing status.69-70 There are 

six key interrelated factors (identified below) that impact 

HIV prevention and treatment efforts addressed through 

the practices highlighted in this guide. 

Stigma, social marginalization, and discrimination

Stigma is a “perennial problem,”71 contributing to 

poor ART adherence, higher rates of depression,72

and challenges related to HIV prevention (e.g., fear 

of disclosure impacting negotiation of condom use).73

Stigmatizing beliefs (e.g., that HIV can be transmitted 

through coughing or sneezing) contribute to a culture of 

social discomfort, prejudice, violence, and discriminatory 

actions (e.g., avoiding interactions with a person they 

know has HIV).73 Stigma and mistrust of medical systems 

may deter individuals from seeking care and from sharing 

with their healthcare providers details about behaviors 

that increase risk of getting HIV (e.g., injection drug use, 

condomless sex) and existing medical conditions (e.g., 

mental illness, SUD, HIV status, testing, and medication 

adherence).

Access to appropriate, tailored, and skilled care

Mental illness and SUD are conditions that present 

barriers to accessing and linking to HIV care, as well as 

initiating and adhering to medication (ART, PrEP, and 

PEP).60, 74-80 Access to treatment is key to reaching viral 

suppression.79 Individuals may experience challenges 

in finding providers that have expertise in HIV, mental 

health, and SUD. Mental illness and SUD treatment 

providers are well positioned to address some of the social 

determinants of health and unmet needs, but they may 

need additional training to address co-occurring HIV.81

Care coordination

Untreated or undertreated mental illness and/or SUD 

can create obstacles to initiating and continuing PrEP 

and ART, increasing the potential for HIV transmission. 

Integrated testing (as previously described) and service 

delivery (e.g., multi-disciplinary teams and one-stop-shop 

models that provide co-located or coordinated substance 

use, mental health, medical, and social services, further 

discussed in Chapter 3) are successful strategies for 

engaging and retaining in care people with or at risk for 

HIV who may have multiple co-occurring health and 

ancillary service needs.82-85 Coordinated care, linkage to 

HIV care, and patient follow-up and monitoring within 

behavioral health settings (further discussed in Chapter 2) 

are also key to facilitating HIV prevention and treatment. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 7

Medical co-morbidities

People with HIV have been shown to be at higher risk 

for cardiovascular disease, hepatic and renal disease, 

osteoporosis and fractures, metabolic disorders, 

skin and soft-tissue disorders, pulmonary disorders, 

central nervous system disorders, and various forms 

of cancer.86-87 Cognitive difficulties can be caused by 

the impact of HIV on the brain (i.e., HIV-associated 

neurocognitive disorder).88-89 Possible side effects and 

interactions from pharmacological therapy, including 

ART and medication for opioid use disorder, may further 

complicate health outcomes.86-87, 90

Viral hepatitis 

People with HIV are disproportionately affected by 

viral hepatitis (hepatitis A virus [HAV], hepatitis B virus 

[HBV], and hepatitis C virus [HCV]). Of those with cooccurring HIV and viral hepatitis, about one third have 

both HBV and HCV. HBV and HCV are bloodborne 

pathogens, which can be spread through needle sharing 

associated with injection-drug use.21 Nearly 75 percent 

of people with HIV who inject drugs also are infected 

with HCV.91 Both HBV and HCV are also associated 

with sexual behaviors that increase risk of HIV (e.g., 

condomless sex). About half of people who have HCV 

do not display symptoms, so it is important that regular 

testing is done.92 Co-occurring HIV and viral hepatitis 

present challenges in managing and treating HIV 

infection.91, 94-95 Hepatitis A, B, and C are all associated 

with liver inflammation and liver damage. When the 

liver is inflamed, it is less able to process medications 

including anti-retroviral medications, which can cause 

worsened side effects of HIV medicine.96 People with 

HIV who contract viral hepatitis are more likely to 

experience a faster progression of liver-related injury 

than people who do not have HIV.21 Medications to 

treat hepatitis are similar to HIV in that they are antiretroviral. However, some medications that treat HIV 

and HCV are not safe to use together, so it is important 

that people with HIV and HCV regularly consult with a 

doctor.94

Incarceration

While the extent of HIV transmission within jails and 

prisons is not fully understood,97-99 the risk of HIV 

is heightened for incarcerated populations compared 

to non-incarcerated populations, namely due to high 

rates of HIV in prisons, inconsistent screening for 

HIV upon entry and release, condomless sex, injection 

drug use equipment sharing, and the labeling of 

condoms as contraband within prisons.100-102 Release 

from incarceration is widely considered an especially 

vulnerable period for both opioid overdose101-103 and 

discontinuation of HIV care and ART treatment provided 

during incarceration. The interruption in care can lead to 

reductions in treatment adherence101, 104 and increases in 

viral loads.101-102

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www.hiv.gov/hiv-basics/overview/history/hiv-andaids-timeline

2 Centers for Disease Control and Prevention. (2019, 

October 17). PrEP. https://www.cdc.gov/hiv/basics/

prep.html
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders 

Issue Brief 8

3 Centers for Disease Control and Prevention. (2019, 

August 6). PEP. https://www.cdc.gov/hiv/basics/pep.

html

4 Fauci, A. S., Redfield, R. R., Sigounas, G., Weahkee, 

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the American Medical Association (JAMA), 321(9), 

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hiv-basics/overview/data-and-trends/statistics

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hiv.gov/federal-response/ending-the-hiv-epidemic/

overview

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Mental health treatment gaps are drivers of 

increased HIV acquisition and poor health outcomes. 

American Psychological Association Psychology 

and AIDS Exchange Newsletter. https://www.apa.

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Grinsztejn, B., Prestage, G. P., Zablotska-Manos, I. 

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Tee, B. K., Templeton, D. J., Cooper, D. A., Emery, 

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9 Centers for Disease Control and Prevention. (2020, 

July 30). ‘Ending the HIV Epidemic’: CDC Role - 

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it’s%20done,spreading%20the%20virus%20to%20

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January 21). HIV testing. https://www.cdc.gov/hiv/

guidelines/testing.html

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jamanetwork.com/journals/jamainternalmedicine/

fullarticle/2130723

13 Moyer, VA US Preventive Services Task Force 

. Screening for HIV: U.S. Preventive Services 

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doi/10.7326/0003-4819-159-1-201307020-00645

14 Background: The Affordable Care Act’s new rules 

on preventive care. CMS.gov website. Published 

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96 Jones, Amelia. (2019, May). Liver disease, hepatitis, 

and HIV. NAM. https://www.aidsmap.com/abouthiv/liver-disease-hepatitis-and-hiv 

97 Centers for Disease Control and Prevention. (2019, 

October 25). HIV by group. https://www.cdc.gov/

hiv/group/index.html

98 Ojikutu, B. O., Srinivasan, S., Bogart, L. M., 

Subramanian, S., & Mayer, K. H. (2018). Mass 

incarceration and the impact of prison release on 

HIV diagnoses in the US south. PloS One, 13(6), 

e0198258-e0198258. https://doi.org/10.1371/journal.

pone.0198258

99 National Center for Innovation in HIV Care, The 

Fenway Institute, & Fenway Health. (2017). Models 

for improving linkage to care for people living with 

HIV released from jail or prison. U.S. Department 

of Health and Human Services. https://targethiv.org/

sites/default/files/file-upload/resources/HIV%20

and%20Incarceration%20Brief.pdf

100 Avert. (2019, October 10). Prisoners, HIV and 

AIDS. https://www.avert.org/professionals/

hiv-social-issues/key-affected-populations/

prisoners#footnote1_pbx20my

101 Sawyer, W., & Widra, E. (2017). Unpacking the 

connections between race, incarceration, and 

women’s HIV rates. Prison Policy Initiative. https://

www.prisonpolicy.org/blog/2017/05/08/hiv/

102 Wohl, D. A. (2016). HIV and mass incarceration 

where infectious diseases and social justice meet. 

North Carolina Medical Journal, 77(5), 359-364. 

https://doi.org/10.18043/ncm.77.5.359

103 Boston University Center for Innovation in 

Social Work & Health. (n.d.) Transitional care 

coordination: From jail intake to community HIV 

primary care. TargetHIV. https://targethiv.org/deii/

deii-transitional-care

104 Beckwith, C., Castonguay, B. U., Trezza, C., 

Bazerman, L., Patrick, R., Cates, A., Olsen, 

H., Kurth, A., Liu, T., Peterson, J., & Kuo, I. 

(2017). Gender differences in HIV care among 

criminal justice-involved persons: Baseline data 

from the Care+ Corrections Study. PloS One, 

12(1), e0169078. https://doi.org/10.1371/journal.

pone.0169078
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 14

2

CHAPTER

What Research

Tells Us

This chapter presents five practices that healthcare 

practitioners can use to prevent and treat human 

immunodeficiency virus (HIV) among people living with 

mental illness and/or substance use disorders (SUD). 

• Practices to increase uptake of and improve 

adherence to Pre-Exposure Prophylaxis (PrEP)

• Syringe Services Programs (SSPs)

• Contingency Management (CM)

• Cognitive Behavioral Therapy (CBT)

• Patient Navigation

Although selected practices are non-pharmacological, 

some are focused on improving uptake and adherence 

to medications. Each practice is described and given 

a rating to assist practitioners, clinic administrators, 

and policy makers in identifying ones that might serve 

their population of focus. This chapter also provides an 

overview of each practice, including a discussion of the 

typical implementation settings, populations that benefit 

from the practices, intensity of services, and practice 

outcomes. 

Practice Selection 

To be considered for inclusion in this guide, eligible 

practices had to meet the following criteria: 

• Must be clearly defined and replicable

• Impact HIV prevention and treatment–related 

health outcomes among people with mental 

illness and/or SUD

• Are currently in use
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 15

• Have accessible technical assistance and support 

for implementation 

Evidence Review and Rating

Authors completed a comprehensive review of published 

research for each selected practice to determine its 

strength as an evidence–based practice. Eligible research 

studies had to be published after the year 2000 and:

• Employ a randomized or quasi-experimental 

design, or 

• Be a single sample pre-post design or an 

epidemiological study with a strong counterfactual 

(i.e., a study that analyzes what would have 

happened in the absence of the intervention).

Descriptive and implementation studies and meta-analyses 

were not included in the review, but were documented 

to provide context and identify implementation supports 

for the practices. Authors included systematic reviews 

when assessing SSPs, as an evidence base for SSPs was 

established pre-2000.*

Each eligible study was reviewed for evidence of 

measurable change in HIV and mental illness and/

or SUD-related health outcomes. In addition, trained 

reviewers checked each study to ensure rigorous 

methodology, asking questions such as: 

•	 Are experimental and comparison groups 

demographically equivalent, with the only 

difference being that participants in the 

experimental group received the intervention 

and those in the comparison group received 

treatment as usual or no/minimal intervention?

•	 Was baseline equivalence established between 

the treatment and comparison groups on 

outcome measures? 

•	 Were missing data addressed appropriately?

•	 Were outcome measures reliable, valid, and 

collected consistently from all participants?

Using these criteria, each study’s causal impact was 

assessed and given a rating of low, moderate, or high. Only 

randomized controlled trials, quasi-experimental designs, 

and epidemiological studies with a strong comparison were 

* Due to concerns raised in the mid-1990s about the ethics of experimental design in SSP research,1-3 researchers have had to rely on 

longitudinal and epidemiological approaches to understand the impact of regular use of an SSP on injection drug use behaviors, 

substance use frequency, substance use treatment enrollment, and HIV incidence, among people who inject drugs. Systematic 

reviews support strong evidence of effectiveness.4-5

eligible to receive a high or moderate rating (see Appendix 

2 for more information about the evidence review process).

After all studies for a practice were assessed and rated, 

each practice was placed into one of three categories 

based on its causal evidence:

• SSPs, CM, CBT, and Patient Navigation have 

strong evidence.

• Practices to Increase Uptake and Improve 

Adherence to PrEP have an emerging evidence 

base. 

Causal Impact: Evidence demonstrating that 

an intervention causes, or is responsible for, 

the outcome measured in the study’s sample 

population.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 16

In the discussion of selected practices, the following 

icons will be used to indicate ways in which the practice 

has been implemented to improve HIV prevention and 

treatment outcomes: 

Practices to Increase Uptake of and Improve 

Adherence to PrEP

Goal

PrEP is a biomedical intervention in which people 

at risk of getting HIV adhere to a regimen of daily 

oral antiretroviral medications. The Food and Drug 

Administration has approved two forms of PrEP 

medication6

 that prevent HIV from multiplying within 

the body. Long-acting injectable forms of PrEP are 

currently being tested.7

The U.S. Preventive Services Task Force gave PrEP 

a Grade A recommendation.8

 It is an effective tool 

for reducing HIV transmission, including among 

populations behaviorally vulnerable to HIV, such as 

people who inject drugs (PWID)9

 and people who may 

be exposed to HIV through sexual contact.10 PrEP is 

approximately 99 percent effective at preventing HIV 

when taken consistently and adhering to prescription 

guidelines.9 PrEP is recommended for people who 

have had an increased risk of getting HIV in the past 6 

months, and the risks/benefits of uptake and continuing 

should be an ongoing discussion between the client and 

provider.

Efficacy of PrEP as a biomedical intervention is 

established. 

However, evidence for interventions that aim to 

increase PrEP uptake and adherence among 

people at risk of HIV who have mental illness and/

or SUD is emerging.

Identification of Practices Associated with HIV 

Prevention and Treatment

While the efficacy of PrEP as a biomedical intervention 

is clear, people may face significant barriers to starting 

and adhering to PrEP, posing obstacles to reaching the 

goals of the Ending the HIV Epidemic (EHE) initiative. 

Barriers include, but are not limited to, the following: 

• Stigma (both of HIV and of taking PrEP)

• Low awareness of the existence of PrEP among

eligible PrEP users

• Low perception of risk of getting HIV

• Concern about possible side effects

• Lack of social support

• Perceived and actual cost

• Difficulty following the daily regimen10

• Health insurance coverage, or health insurance

that does not cover laboratory and clinical

visits11-13 

• Limited access to care (e.g., transportation,

hours of services)

Mental illness and/or SUD may compound these barriers. 

Since the effectiveness of PrEP as a biomedical 

intervention has been established, this evidence review 

examines psychosocial supports to increase uptake and 

adherence to PrEP. These psychosocial interventions 

include the following:

• PrEP Mate: A bidirectional text-messaging

program, grounded in the information,

motivation, and behavioral (IMB) theory of

behavior change, involving daily text reminders

to take PrEP and weekly text check-ins.18

• Bio-Behavioral Community Health Recovery

Program (CHRP-BB): A weekly group therapy and

text-message reminder intervention encouraging

PrEP adherence and teaching health management

skills for people who are vulnerable to HIV

(through injection drug use or condomless sex).19

• Pharmacy-led PrEP (P-PrEP): An integrated

care intervention in which an in-clinic pharmacist

consults with the client and prescribes PrEP the

same day that the client tests negative for HIV.15

Prevention Treatment 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 17

• Individuals who reported binge drinking over 

the past 3 months19

• PWID19

• People who test negative for HIV17

PrEP should not be prescribed to people with HIV (as it 

is an inappropriate medical intervention for HIV) and/or 

people with severe renal insufficiency.10

Practitioner Types

A diverse range of behavioral health practitioners and 

clinical providers can implement practices to increase 

PrEP uptake and adherence, including:

• Clinic and research staff18

• Graduate-level trained facilitators19

• Pharmacists15-17

Intensity and Duration

While PrEP can be taken indefinitely, intensity and 

duration of individual practices to support PrEP uptake 

and adherence vary depending on the intervention.

• PrEPMate includes daily text reminders to take 

PrEP and weekly check-in texts about PrEP 

adherence, side effects, and attitudes around 

PrEP sent from clinicians18-19

• CHRP-BB includes four 50-minute weekly 

group meetings that address behaviors related 

to increased risk of getting HIV and increased 

PrEP adherence and daily text reminders to take 

PrEP19

• P-PrEP includes same-day PrEP referral by a 

pharmacist and follow-up appointment with a 

clinician within 6 weeks17

Outcomes Associated with Practices to Increase 

Uptake and Improve Adherence to PrEP

•	 Increased PrEP uptake, sustained for 

up to 9 months.15-17

•	 Increased PrEP adherence, 

sustained for up to 12 months.15-19

Typical Settings

Practitioners can implement practices designed to 

increase PrEP uptake and adherence in diverse mental 

illness, SUD, and HIV treatment settings, including the 

following: 

• Safety net health clinics focused on HIV 

prevention and treatment18

• Mobile application that extends the reach of 

PrEP support18

• Methadone maintenance clinics19

• Non-clinical testing centers; pharmacies; 

community health centers15-17

Demographic Groups

Several categories of people can benefit from practices 

designed to increase PrEP uptake and adherence, including:

• Young men (mean age of 24) who have sex with 

men (MSM)19

• Individuals who reported recreational drug use19

Safety-net clinics provide care to individuals who 

have limited or no access to health care (as a 

result of financial circumstances, insurance status, 

or health conditions).20

Syringe Services Programs (SSPs)

Goal

SSPs reduce the risk of infectious disease associated with 

injection drug use through preventive services, including 

provision of sterile syringes, injection drug equipment, 

and harm reduction education, as well as linkage to HIV 

and mental illness and/or SUD treatment.21-23

Decades of research demonstrate the efficacy and 

importance of SSPs in reducing the transmission of 

infectious diseases, including HIV and hepatitis C virus 

(HCV).24 Due to concerns raised in the mid-1990s about 

the ethics of experimental design in SSP research,1-3

researchers have had to rely on longitudinal and 

epidemiological approaches to understand the impact of 

regular use of an SSP on reductions in harm associated 

with injection drug use, substance use frequency and 

treatment enrollment, and HIV incidence among PWID. 

SSPs have been shown to reduce HIV and HCV 

incidence by approximately 50 percent and are a key 

practice identified in the EHE initiative.25-26 Additionally, 

SSPs have been effective in engaging hard to reach 

populations, as SSPs reduce typical barriers to entry 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 18

who also inject. As a result, SSPs can facilitate a 

larger number of sterile syringes available within a 

community.33, 37

Practitioner Types

SSP activities can be conducted by: 

• Pharmacists, pharmacy managers, clerks, 

and technicians dispensing over-the-counter 

syringes34, 38

• Care service coordinators31 and outreach 

workers39

• Professional staff and volunteers (including 

trained healthcare professionals)

These personnel are best equipped to take on these roles 

when provided with overdose prevention and response 

training and appropriate education about sterile syringe 

distribution and needle-stick injuries.40-41

Intensity and Duration

SSPs are structural interventions designed to impact 

population health.38 Implementing an SSP is less about 

a specific number of interactions with PWID, and more 

about providing consistent, stable access to sterile 

syringes to increase the volume of sterile syringes 

available in a given community (benefiting both direct 

participants of SSPs and their networks). 

However, the higher the number of interactions with 

SSPs, the more opportunities a provider has to offer 

additional harm reduction education materials (e.g., 

naloxone kits, PrEP, PEP) and SUD treatment. 

Studies in this evidence review identified the following 

factors as affecting the success of service provision:

• Operating hours: Due to limited funding, SSPs 

may restrict their hours, potentially reducing 

interactions with clients and the number 

of syringes provided (at the individual and 

community levels).34

• Location of the SSP: The distance between 

an individual’s home and the SSP has been 

identified as a barrier to accessing SSPs.32, 34, 39

• Number of syringes provided: SSPs can 

provide sterile syringes (not purchased using 

federal funding) in single or multiple day 

supplies, based on the number of syringes 

returned and reported injection frequency.31

(e.g., clients do not need insurance coverage, prescheduled appointments, referrals)7

 and can adjust 

delivery venues to meet community needs (e.g., fixedsite or mobile exchange vans).28 SSPs are also a prime 

setting for implementing combined interventions, 

including medication for opioid use disorder.29

Outcomes Associated with SSPs 

• Reduction in self-reported receptive 

syringe sharing (i.e., using a previously 

used syringe)30-33

• Increase in frequency of injecting with 

a sterile syringe, as opposed to a nonsterile syringe31, 34

• Reduction in self-reported sharing 

of injection equipment and/or 

paraphernalia31-33

• Reduction in HIV incidence30

• Reduction in self-reported substance 

use frequency35

Typical Settings

SSPs are community-based interventions that vary 

significantly based on implementation setting, 

geographic location, scope, and services to meet local 

community needs.26, 36 The eight studies in this evidence 

review showed that SSPs have been effective in both 

urban and rural settings and have operated successfully 

as both long-standing programs and temporary 

emergency public health responses to HIV outbreaks. 

SSPs have also been effective in both fixed-site and 

mobile settings.30-31

Demographic Groups

PWID, regardless of gender, age, education, marital 

status, income, or housing status, can benefit from 

consistent availability of sterile syringes provided 

through SSPs.34 Access to sterile injection drug 

equipment, harm reduction education, and linkage 

to treatment through SSPs22 can lead to reductions in 

harm associated with injection drug use, substance use 

frequency, and overall HIV incidence.30-35

Geographic proximity may also impact an individual’s 

ability to access an SSP, suggesting that populations 

living near SSPs benefit most from their services.32

In this practice, individuals can acquire large numbers 

of syringes to distribute to their networks of others 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 19

Contingency Management (CM) 

Goal

CM is a behavioral therapy that uses motivational 

incentives and tangible reinforcers to increase desirable

behavior.42-43 People in CM programs are given 

reinforcers—often vouchers that can be exchanged for 

money or goods, or chances to win prizes—when they 

consistently demonstrate positive behavior (e.g., negative 

urine drug screens, showing up for an appointment).44

Many state Medicaid, Medicare, and private insurance 

entities may not reimburse for CM reinforcers. Additionally, 

the Department of Health and Human Services’ (HHS) 

Office of the Inspector General (OIG) has ruled that the 

Centers for Medicare and Medicaid Services (CMS) may 

not provide more than $75 annually (or $15 per individual 

appointment) in goods to beneficiaries, limiting CM 

enforcers to that amount.45-47 Medicaid, Medicare, and 

private insurance agencies may reimburse for CM as a 

service, but any value of payment for the reinforcers is 

prohibited. Therefore, CM implementation requires careful 

coordination with HHS, the state health department, and 

other insurance providers. Providers wishing to implement 

CM may identify other funding for reinforcers (up to $75 

per beneficiary annually), including federal, state, and 

private grants, as well as contributions from or opportunities 

to share costs with community partners. 

Practitioners can implement CM along with individual 

or group counseling or in conjunction with scheduled 

medical visits, including urine drug screens, daily 

methadone dosing, or HIV-related appointments.48-49

Outcomes Associated with CM

CM is an effective psychosocial intervention for reducing 

substance use and maintaining substance use abstinence 

for periods of up to 1 year.50 In 2006, researchers began 

testing CM principles in the prevention and treatment of 

HIV.51 Behavior change takes time, and while CM has 

been shown to be effective for periods up to one year, it 

is important to note that these may be temporary changes 

for life-long disorders. HIV prevention and treatment 

outcomes attributed to CM are outlined below: 

• Reduction in self-reported sexual 

behaviors that increase risk for HIV 

over the previous month (i.e., number 

of sexual partners, condomless sex, 

sex for money or nonmonetary items, 

and anal sex) sustained for up to 12 

months.42, 44, 48

• Reduction in self-reported drug-use 

behaviors that increase likelihood for 

getting HIV over the previous month, 

(i.e., injection drug use, receptive 

syringe sharing, syringe lending, and 

using injection drug use equipment 

that has not been cleaned or sterilized) 

sustained for up to 12 months.42, 48-49

• Reduction in viral load, sustained for 

up to 6 months.44, 52

• Increase in adherence to antiretroviral 

therapy (ART), sustained for up to 4 

months.53

Typical Settings

Practitioners can use CM across a variety of outpatient 

and inpatient settings and across urban, suburban, and 

rural settings, including:

• Outpatient treatment clinics42, 44, 48-49, 52

• SUD treatment settings (e.g., methadone 

clinics)49

• Counseling centers42, 25

• HIV-focused drop-in centers44

Demographic Groups

• CM has been effective in preventing 

HIV among adults aged 18 to 65, living 

in urban and suburban areas, who 

use cocaine and opioids and who are 

taking methadone. It has also been 

effective among adults who engage 

in sexual and drug use behaviors that 

increase likelihood of getting HIV.42, 44, 

48-49

•	 CM is effective in increasing linkage 

to and retention in HIV care among 

people with co-occurring HIV and SUD 

including adults aged 18 to 65, living in 

urban and suburban settings, with HIV, 

and who use cocaine and opioids It 

has also shown efficacy among PWID 

and adults who take methadone.42, 44, 

48-49, 52
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 20

Practitioner Types

CM can be implemented by a variety of practitioners, 

including: 

• Counselors42, 53

• Post-doctoral fellows in psychology (who 

are provided with supervision from licensed 

psychologists)44

• Clinic staff with education levels ranging from 

no bachelor’s degree to master’s degree in social 

work 48-49

Formal CM-specific training is not required, but training 

or coursework in behavioral analysis is available to 

support implementation of this practice.

Intensity and Duration 

CM does not require a prescribed number of sessions 

or specified length of individual sessions, and has 

demonstrated efficacy when implemented in the 

following settings for the following durations:

• An intensive outpatient setting with daily 

counseling over 6 weeks48

• A methadone clinic with daily methadone dosing 

and weekly individual and group counseling 

over 12 weeks42, 49

• A counseling center with individual counseling 

over 16 weeks52

• A counseling center with weekly group 

counseling sessions over 24 weeks44

CM can also act as a “buy-in” for other behavioral 

interventions associated with longer-term benefits. For 

example, when combined with counseling, it may increase 

attendance at sessions, which in turn can have long-term 

therapeutic benefits.48

Cognitive Behavioral Therapy (CBT)

Goal

Providers in mental health settings are uniquely positioned 

to prevent HIV and support linkage and retention in HIV 

care and ART adherence for people with HIV. Through 

individual and group counseling such as CBT, providers 

can build “reciprocal, robust, and trusting relationships” 

by having consistent and confidential interactions with 

clients over time.54

CBT is a form of psychotherapy that seeks to modify 

problematic thinking, beliefs, or behavior through skillbuilding. CBT programs share three core principles. They 

are 1) goal-oriented; 2) time-limited; and 3) structured.55

CBT helps individuals identify specific problems and gain 

the skills to manage and solve them.56 All studies included 

in this evidence review employed the core components 

of CBT (basing individual and group work on thoughts, 

feelings, emotions, and skill-building). 

This evidence review includes specific applications of 

CBT for mental health clinicians to use with clients living 

with mental illness and/or SUD with and at risk for HIV, 

detailed below:
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 21

Cognitive Behavioral Skill Building Intervention (E-CB)

E-CB facilitates HIV prevention through structured sessions on the following topics:

• HIV education, including personalizing risk of getting HIV, condom use and negotiation skills and 

identifying situations with increased risk of getting HIV

• developing and practicing problem solving, assertiveness, and communication training approaches.57

Cognitive Behavioral Therapy for Trauma and Self Care (Project Thrive)

Project Thrive addresses posttraumatic stress responses in MSM with histories of childhood sexual abuse 

who are at increased risk for HIV. This individual therapy model integrates counseling for sexual health 

with cognitive and behavioral strategies as a feasible and acceptable treatment among MSM to effectively 

reduce sexual risk for HIV and decrease post-traumatic stress disorder (PTSD) symptom severity.58-59

Behavioral Activation for Methamphetamine Dependence (Project IMPACT)

Project IMPACT is an individual therapy intervention that aims to reduce crystal methamphetamine use and 

condomless sex among MSM. This integrated treatment consists of behavioral activation, an evidencebased approach for depression that involves identifying and participating in pleasurable, goal-directed 

activities, and CBT with HIV sexual risk counseling.60

Cognitive Behavioral Therapy for Social Anxiety and Sexual Health (Sexual Confidence) 

Sexual Confidence adapts the CBT framework for social anxiety to include substance use management 

in interpersonal situations and reducing sexual behaviors that increase likelihood of getting HIV through 

sessions on the following:

• setting goals related to reducing risk of getting HIV and reducing social anxiety

• the role of social anxiety and substance use in increasing risk of getting HIV

• discussing and practicing coping skills for anxiety reduction61-62

Cognitive Behavioral Therapy for HIV Medication Adherence and Depression (CBT-AD)

CBT-AD integrates continued adherence counseling with traditional CBT techniques for the treatment of 

depression. CBT-AD uses proactive problem solving, action planning, and motivational interviewing to:

• facilitate behavior change63

• address the cognitive and behavioral patterns commonly experienced by adults with co-occurring 

depression and HIV64

• improve ART adherence63

Outcomes Associated with CBT

• Reduced sexual behaviors that increase likelihood of getting HIV, including improved attitudes towards 

condom use and greater condom use skills, sustained for up to 6 months57,62, 65-66

• Reduced PTSD and depression symptom severity for up to 9 months58, 60

• Reduction in crystal methamphetamine use for up to 6 months66

• Increased perceived susceptibility to getting HIV, defined as perceptions of personal vulnerability to HIV 

disease, sustained for up to 6 months57

• Reduction in viral load, sustained for up to 12 months67

• Increase in adherence to ART, sustained for up to 15 months63, 68-70
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 22

Typical Settings

Practitioners can incorporate CBT in mental illness 

and/or SUD and social service settings including:

• Academic medical centers65

• Outpatient treatment centers57

• Methadone clinics63

• Homeless shelters71

• Community health clinics69

Demographic Groups

CBT is a well-established, effective treatment for people 

with mental illness and/or SUD who have or at risk for 

HIV. It is appropriate for anyone who can relate to the 

CBT core components, problem-solving approach, and 

structure, including:

• Men who have sex with men (MSM) 

who are at risk for HIV61, 71

• People with severe mental illness at 

risk for HIV57

• People with at least one HIV-related 

risk behavior, including self-reported 

injection drug use, two or more sex 

partners in the past 90 days, or having 

a partner with HIV65

• People with a history of child sexual 

abuse and at risk for getting HIV58

• People with co-occurring HIV and 

depression68-69

• People with co-occurring HIV and 

depression who inject drugs63

Practitioner Types

CBT can be implemented effectively by a variety of 

professionals including:

• Clinical psychologists63

• Master’s level psychologists,68 social workers, 

and counselors

• Case managers72

• Facilitators with an average of 10 years of 

experience leading group-based HIV prevention 

interventions with people who use drugs65

Practitioners do not need to be certified to practice CBT, 

but certifications are available.73

Intensity and Duration

CBT generally provides the tools for behavior change in 8 

to 12 individual or group sessions, meeting once or twice 

weekly, with each session lasting between 60 and 90 

minutes.74 The length of treatment also varies depending 

on the individual’s symptoms, resources, and preference. 

As highlighted below, studies included in this evidence 

review varied by time and number of sessions. 

The E-CB intervention consists of six 

90-minute sessions over the course of 6 

weeks. Weekly sessions gave participants 

time to practice lessons between sessions, 

reinforcing content discussed during the 

sessions.57

Project Thrive consists of approximately 10 

individual therapy sessions on integrated 

cognitive therapy strategies, behavioral 

techniques, and sexual risk reduction 

counseling.58

Project IMPACT consists of 10 weekly, 

50-minute, in-person sessions that include 

HIV risk reduction sessions, sessions of 

cognitive behavioral therapy for reducing 

substance use, behavioral activation 

sessions, and preventing re-starting 

substance use.60

Sexual Confidence consists of 10 weekly 

1 hour sessions using an integrated CBT 

model focusing on conversations between 

the client and facilitator (instead of a 

didactic learning session).62

CBT-AD consists of between nine and 12 

50- to 60-minute sessions, with three “open 

sessions” (which allow for the individual 

and therapist to revisit the modules that 

are most relevant to the client’s specific 

needs).63, 64, 67, 69
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 23

Patient Navigation

Goal

Patient navigation is a client-centered approach aimed 

at improving care engagement by addressing client and 

system barriers, and helps clients access medical and 

support services in an often complex healthcare system.75

Originally developed as a strategy to improve timely 

access to cancer screening, diagnosis, and treatment,76

patient navigation has been used to improve the health 

outcomes of multiple medical conditions, including 

HIV. During individual sessions, navigators work with 

participants to facilitate access to care, review health 

information, overcome personal or logistical challenges, 

and provide psychosocial support by promoting selfefficacy and problem-solving behaviors. In addition to 

the sessions, navigators accompany participants to HIV 

care and SUD treatment appointments. 

In the context of the HIV-care continuum, patient 

navigation services typically focus on linkage to and 

retention in care, improving HIV treatment outcomes, 

client satisfaction, and client self-management.77

Outcomes Associated with Patient Navigation

• Viral suppression, sustained up to 12 

months78

• Linkage to HIV care, with the greatest 

probability of linkage occurring within 6 

months53, 78

• Retention in HIV care, sustained up to 

12 months78

• Adherence to ART medications, 

sustained up to 12 months53

Typical Settings

Practitioners can provide patient navigation services in a 

wide range of treatment settings including:

• Correctional and criminal justice settings78

• Mental illness and/or SUD treatment programs79

• Primary health and HIV-specific care clinics53

• Hospitals53

Demographic Groups

Patient navigation can be used with a variety of populations, 

but is often targeted for those at highest likelihood of not 

linking to or continuing in care80 including:

• People with HIV, aged 18 or older, who 

report recent use of substances (i.e., opioids, 

stimulants, alcohol)53

• People with HIV (specifically men and 

transgender women) transitioning from jail to 

the community78

Practitioner Types

Patient navigation can be implemented effectively by a 

variety of professionals including:

• Medical professionals or clinical staff, 

community members, social workers, and other 

diverse professionals (e.g., case management, 

discharge planning, criminal justice system)77

• Peer patient navigators78

PATIENT NAVIGATION:

Supporting transition between jail 

and community 

While incarcerated, people with HIV often achieve 

viral suppression due to the highly structured 

environment and consistent access to care. Postrelease delays in linkage to and retention in care 

can cause declines in viral suppression.74 

Peer patient navigators with shared lived 

experiences can play a key part in facilitating 

linkage to care by acting as role models. In 

the study included in this review, peer patient 

navigators established relationships with 

participants before they left jail, met them at the 

time of release, provided referrals for post-release 

housing and SUD treatment, and counseled them 

on retention and adherence behaviors in HIV care.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 24

Patient navigators often share qualifications and skills 

with other support service providers in clinical settings, 

such as advocates, health educators, or case managers.74

Matching peer patient navigators with individuals who 

have similar experiences is a successful approach for 

linking and retaining clients in HIV care81 and can play a 

key role in building social networks and establishing trust, 

especially among stigmatized populations.82

Intensity and Duration

Patient navigation services are customized to the specific 

needs of clients, so there is no standard model for the 

intensity and duration of the program.80 Typically, 

navigators meet regularly with clients for 11 to 12 

individual sessions over 6 months, and their work 

continues through a predetermined endpoint (determined 

by the clinic model). In the case of HIV care, this 

endpoint is often linkage to care.77
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 25

Summary of Evidence-based Review 

Practice Practices to 

Increase Uptake 

of and Improve 

Adherence to 

PrEP

Syringe 

Services 

Programs 

(SSPs)

Contingency 

Management (CM)

Cognitive 

Behavioral 

Therapy (CBT) 

Patient

Navigation

Review 

Rating

Emerging 

Evidence

Strong Evidence Strong Evidence Strong Evidence Strong Evidence

Focus of the 

practice 

Practices 

designed to 

overcome barriers 

to initiating and 

sustaining PrEP 

use. 

A harm reduction 

method for 

reducing the 

likelihood of 

HIV and HCV 

associated with 

injection drug 

use.

Focus on positively 

rewarding desired 

behaviors. 

Focus on helping 

clients improve their 

quality of life not 

by changing their 

circumstances, but 

by altering their 

perceptions of those 

circumstances.

A client-centered 

approach aimed 

at improving 

engagement in HIV 

care by addressing 

client and system 

barriers.

Can be used 

in out-patient 

healthcare 

settings 

    

Can be used 

in in-patient 

healthcare 

settings

 -   

Specific 

training 

available 

  -  

Can be 

practiced by 

peers

-  - - 

Special 

populations 

with whom 

the practice 

has been 

successfully 

implemented 

Young MSM; 

PWID or 

recreationally use 

drugs

PWID Individuals with cooccurring HIV and 

SUD; individuals who 

engage in sexual or 

drug use behaviors 

that increase 

likelihood of getting 

HIV

MSM; individuals 

with severe mental 

illness; individuals 

with co-occurring 

HIV, mental illness 

and/or SUD

Individuals with 

SUD; men and 

transgender women 

transitioning from 

jail to community

Intensity and 

duration 

Indefinite Indefinite No prescribed 

intensity or duration; 

shown to be 

effective for between 

6 to 24 weeks

Varies depending 

on specific CBT 

intervention 

implemented, 

ranges from 1 to 

2 weekly sessions 

over the course of 8 

to 12 weeks

No prescribed 

intensity or duration; 

typical range of 11 

to 12 sessions over 

6 months 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

What Research Tells Us 26

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of “Life-Steps for PrEP”. AIDS and Behavior, 21(5), 

1350-1360. https://doi.org/10.1007/s10461-016-

1606-4

72 Linn, J., Neff, J. A., Theriot, R., Harris, J., Interrante, 

J., & Graham, M. (2003). Reaching impaired 

populations with HIV prevention programs: A 

clinical trial for homeless mentally ill AfricanAmerican men. Cellular and Molecular Biology 

(Noisy-le-Grand, France), 49(7), 1167-1175. https://

pubmed.ncbi.nlm.nih.gov/14682400/

73 Beck Institute. (2019). Beck CBT certification. 

https://beckinstitute.org/certification/

74 Foa, E. B., Keane, T. M., Friedman, M. J., & 

Cohen, J. A. (2009). Effective treatments for PTSD: 

Practice guidelines from the International Society for 

Traumatic Stress Studies (2nd ed.). Guilford Press. 

75 Boston University Center for Innovation in Social 

Work & Health (2016). Enhanced patient navigation 

for HIV-positive women of color. TargetHIV. https://

targethiv.org/deii/deii-enhanced-patient-navigation

76 Harold P. Freeman Patient Navigation Institute. 

(2020). Our model: The gold standard. http://www.

hpfreemanpni.org/our-model/

77 Farrisi, D., & Dietz, N. (2013). Patient navigation 

is a client-centered approach that helps to engage 

people in HIV care. HIV Clinician, 25(1), 1-3. 

https://pubmed.ncbi.nlm.nih.gov/23476957

78 Cunningham, W. E., Weiss, R. E., Nakazono, 

T., Malek, M. A., Shoptaw, S. J., Ettner, S. L., 

& Harawa, N. T. (2018). Effectiveness of a peer 

navigation intervention to sustain viral suppression 

among HIV-positive men and transgender women 

released from jail: The link la randomized clinical 

trial. JAMA Internal Medicine, 178(4), 542-553. 

https://doi.org/10.1001/jamainternmed.2018.0150 

79 Center for Health Policy and Inequalities Research. 

(n.d.). Including peers as part of a substance use 

treatment program for individuals living with HIV: 

The peer assisted treatment of HIV and substance 

(PATHS) model. http://chpir.org/wp-content/uploads/

paths_model.pdf

80 Broeckaert, L., & Challacombe, L. (2014, August 

11). Health navigation: A review of the evidence. 

Remedy Health Media. https://www.thebodypro.

com/article/health-navigation-a-review-of-theevidence

81 Cabral, H. J., Davis-Plourde, K., Sarango, M., 

Fox, J., Palmisano, J., & Rajabiun, S. (2018). Peer 

support and the HIV continuum of care: Results 

from a multi-site randomized clinical trial in 

three urban clinics in the United States. AIDS and 

Behavior, 22(8), 2627-2639. https://doi.org/10.1007/

s10461-017-1999-8

82 AIDS United. (2015). Best practices for integrating 

peer navigators into HIV models of care. https://

www.aidsunited.org/data/files/Site_18/PeerNav_

v8.pdf
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 31

3

CHAPTER

Guidance for Selecting 

and Implementing 

Evidence-based 

Practices

This chapter discusses key implementation considerations 

to address the challenges of implementing programs 

for human immunodeficiency virus (HIV) prevention 

and treatment among people with mental illness and/

or substance use disorders (SUD). It covers steps from 

practice selection and program funding through engaging 

and retaining people in care. 

Prior to implementing practices identified in Chapter 2, 

each program or clinic should conduct a needs assessment 

to understand the following factors:

•	 Client population (e.g., the population of focus, 

their unique HIV-related risk factors,1

 cultures, 

challenges, and assets)

•	 Existing protocols and procedures that could 

facilitate or become barriers to implementation 

(e.g., intake procedures)

•	 Local factors that could impact service delivery 

(e.g., partnerships with community-based 

organizations and service providers, geography, 

transportation, and socio-political climate)2

•	 Program or organizational strengths, resources, 

and areas for development (e.g., organizational 

leaders and program champions, budget, 

available health insurance reimbursement 

to support planned activities, staffing and 

infrastructure, and information management 

support)3

•	 Training opportunities (program-specific and 

ongoing professional development)
ADAPTING AND TALORING 

THE PRACTICE

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 32

Strategies

Program administrators and clinic leadership can:

• Identify and consistently implement key

characteristics (or core components) of each

practice to generate anticipated outcomes.1, 9

Outside of the core components, organizations

can use their needs assessment to identify

local-level adaptations that will improve service

delivery to their client population.10

• When adapting a program, organizations should

strive to preserve the setting (e.g., outpatient

clinic, mobile health unit), maintain the

prescribed dosage, and, if necessary, add rather

than remove content.11

• Use a systematic process, such as the ADAPTITT model, to balance local program adaptation

needs and adherence to the instructions provided

in the original model.5

• Engage existing and potential clients in project

planning, practice selection, and materials

development. Members of the client community

will have insight into ways to make programs

culturally appropriate, reflecting a community’s

preferred language, attitudes, beliefs, values, and

experiences.

• Assess and address staff and client health

literacy,12-13 and ensure materials meet federal plain

language and National Standards for Culturally and

Linguistically Appropriate Services guidelines.14-15

• Adapt and tailor client care plans and

individualize case management approaches to

meet the unique needs of the client. Effective case

management is a client-driven process where the

case manager and client collaborate on a care

plan, including specific goals for prevention or 

treatment, and then continue to communicate to

ensure the client is able to reach their goals.

Based on the needs assessment, practitioners can 

work with their clinical teams, administrators, leaders, 

and community members and partners to take the 

following steps to identify practices that are appropriate 

and feasible given available resources and local 

characteristics:

• Identify prevention and treatment priorities

• Identify desired short- and long-term outcomes

• Map resources (e.g., housing, employment,

transportation, legal services) available within

the local area to effectively connect clients with

needed services

• Develop a logic model (a graphic depiction of

the relationship between a program’s activities

and their intended outcomes)4

Implementation 

Challenges and Strategies

This chapter includes strategies to promote 

implementation and appropriate adaptation of 

practices to the population of focus, as well as specific 

implementation tools for the programs and practices 

described in Chapters 2 and 4. Key considerations 

described in this chapter include:

• Adapting and tailoring the practice to meet the

needs of the client population

• Care coordination

• Workforce capacity and development

• Access to services

• Financing

Challenge

Practices implemented without adaptation may not 

be relevant to or acceptable for the client population.5

Practices should be culturally relevant, available in the 

appropriate language, and produced at the appropriate 

reading level.6-7

Core components are defined by SAMHSA in the 

Strategic Prevention Framework as “those parts 

of a program or practice that are responsible 

for producing positive outcomes, and thus most 

essential and indispensable.”8
COORDINATING CARE

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 33

Challenge

People at risk for or with HIV who also have co-occurring 

mental illness and/or SUD experience complex medical 

comorbidities. Fragmented behavioral health and HIV 

primary care services make it difficult for practitioners to 

communicate with each other and their clients, potentially 

leading to poor HIV and mental illness and/or SUD 

outcomes.16

Moreover, fragmented care systems place a burden 

on the clients as they become the ones responsible for 

communicating sometimes complex health information 

among practitioners. Ancillary needs (e.g., housing,

childcare, transportation, food insecurity, employment), 

which are critical to clients seeking or engaging in 

care, may also be difficult to address in a fragmented 

system.17-20

Strategies

Effectively addressing these interrelated conditions takes 

a coordinated approach21 between mental illness and/

or SUD and HIV care providers, and other agencies and 

stakeholders that are well-positioned to address the social 

determinants of health. Coordinated models may feature 

screening for mental illness and/or SUD using validated 

tools; team-based care, including both physician and 

non-physician staff; shared IT and electronic medical 

record systems to facilitate communication within care 

teams; and systematic measurement and review of patient 

outcomes.

When HIV clinics screen for mental illness and SUD and 

are able to provide coordinated care to address mental 

illness, SUD, and HIV, clients are more likely to reach 

viral suppression than their counterparts visiting HIV 

primary care services without coordinated mental health 

and substance use services.32 Coordinated services help 

practitioners streamline service delivery to address unmet 

needs. 
WORKFORCE CAPACITY 

AND DEVELOPMENT

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 34

Practitioners can use the following strategies to determine 

the level of integration feasible and appropriate within 

their organization:

• Identify leaders within clinical networks and

health systems who can champion integration

and advocate for coordination, co-location,

and integration over time.21 Integration

takes administrative, political, and financial

investments, as well as cultural change and

different ways of communicating among care

teams and clinics.

• Modify funding structures, billing codes, and

procedures to account for new coordinated

models and consultation between practitioners.21

• Permit data sharing across AIDS-Service

Organizations, social and health service

practitioners, behavioral health specialists,

and the department of corrections to increase

service coordination.33 When sharing data across

organizations, review updated laws, policies,

and regulations on confidentiality to maintain

compliance and protect client information34

and obtain consent from clients for data sharing

during client assessment and intake.

Collaborative Care involves increased collaboration between behavioral healthcare management, mental 

health, and primary care providers. This model includes taking a team-based, client-centered, collaborative 

approach to elements of client care, such as client registries, client education, screening or assessment tools, 

adherence monitoring, and evidence-based treatment guidelines.22-23

Integrated Care involves merging primary health care, mental illness and/or SUD screening and treatment, 

additional medical services (e.g., hepatology, dermatology), and social services (e.g., housing, employment) 

into one treatment plan. These linkages improve client outcomes by combining efforts such as referrals, case 

planning, and resources.23-26

The two terms are not interchangeable, and exist on a continuum.27 For example, a system can collaborate while 

having separate EHR, billing, and scheduling systems. A system can also have integrated care with co-located 

services where practitioners collaborate and case-conference to discuss client care. 

Examples of coordinated care models include patient centered medical homes,28 primary care case 

management arrangements,29 co-located or limited capacity primary care in behavioral health organizations,29

SAMHSA’s Primary Care and Behavioral Health Integration model,30 and Certified Community Behavioral Health 

Clinic models.31

eChallenge

Behavioral health treatment practitioners and their 

clinical teams (e.g., case managers, clinical coordinators) 

are well positioned to address unmet needs (e.g., 

transportation, housing, employment, childcare), but 

may need additional training to address co-occurring 

infectious diseases.35

Practitioners who deliver services aimed at preventing 

and treating HIV among people experiencing cooccurring mental illness and/or SUD may need training 

and capacity building in the following areas:

• Practice-specific training to facilitate consistent

implementation

• Working with clients who have co-occurring

HIV and mental illness and/or SUD

• Creating a culturally appropriate, nonjudgmental, and non-stigmatizing clinical

environment supportive of both clients and

staff36-39
ACCESS TO SERVICES 

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 35

Strategies

Provide intervention-specific training to implement the 

practices.

• Receiving customized, site-specific training

can be resource intensive, and the provision

of program-specific training and technical

assistance may be dependent on grant awards. In

recent years, federal funders have emphasized

the need for replicable practice models that are

easy to adapt, scale up, and implement in the

absence of technical assistance, leading to an

increase in robust training resources available

online. These models include:

− CDC’s Effective Behavioral Intervention

(EBIs) models 

− HRSA’s Dissemination of Evidence Informed Interventions (DEII) model

− HRSA’s Evidence-Informed Interventions 

(E2i) models

• Program managers and practitioners should

select implementation trainings that are not

overly cumbersome or time consuming.40

Provide cross-disciplinary training and institutional 

support to practitioners to facilitate better understanding 

of different disciplines and ways to promote coordinated 

client care.

• Promote cross-training provided by the AIDS

Education and Training Centers (AETCs) on

HIV-related programs, policies, and practices to

both Ryan White HIV/AIDS Program (RWHAP)

and behavioral health practitioners. Similarly,

promote training offered by SAMHSA’s

Prevention, Mental Health and Addiction

Technology Transfer Centers for practitioners

and volunteers providing care for persons with

and at risk of HIV.

• Create mechanisms for staff to work and train

across HIV and behavioral health service

programs.41

• Identify in-house trainings (e.g., grand-rounds,

in-service trainings), local trainings, online

webinars, opportunities to attend conferences,

and continuing education unit training

opportunities to support cross-disciplinary

learning.9

• Prevent vicarious trauma (i.e., work-related

trauma due to continuous exposure to victims of

trauma and violence),42 burnout, and turnover by

supporting manageable caseloads for staff and 

providing consistent clinical supervision. For 

example, peers and patient navigators may not 

have the formal clinical training their licensed 

mental health, substance use, and social work 

colleagues do, and may benefit from ongoing, 

structured clinical supervision.43

Provide ongoing trainings on ways to create welcoming, 

supportive environments for people with or at risk for HIV. 

• Conduct and support staff training to enhance

cultural competence and create a safe, supportive

environment that improves client-staff

relationships and reduces the risk of a client

discontinuing treatment.33

• Include sessions on non-stigmatizing language44

and trauma-informed practices45-46 to improve

client interactions with all staff (from the front

desk, to their nurse, to the billing department).

Challenge

Linkage to and retention in care requires connection 

between the client and the provider. However, 

transportation and geographic barriers can make inperson, face-to-face connections challenging. 

• Transportation-related challenges can include

having to travel long distances to clinics,39

inability to afford gas or fares for public

transportation, and unreliable or lack of access

to a personal vehicle or public transportation for

travel to appointments.38

• People with HIV in rural areas are less likely

to receive HIV care or be engaged in ART

as a result of limited availability of HIVspecific practitioners, provider discrimination,

confidentiality concerns, and lack of financial

resources.47 Geographic barriers can be

compounded by HIV-related stigma where

individuals may be reluctant to seek HIV

prevention or treatment services in a small town

or community for fear they may be “outed.”48
FINANCING

Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 36

Strategies

Program administrators and practitioners can overcome 

these challenges by employing the following strategies:

• Telehealth - Telehealth can connect clients with

specialty practitioners and provide access to

services without having to travel.49 Telephonebased Cognitive Behavioral Therapy (CBT),

as an example, has been shown to reduce

depressive symptoms and improve ART

adherence among people with HIV.50

• Transportation assistance - Vouchers for gas

or public transportation can help eliminate

worry about missing appointments due to

transportation cost-related barriers.51 In one

model, peer navigators provided transportation

to appointments for the first month to give

clients sufficient time to establish a long-term

transportation plan.52 Ride share companies may

also provide travel assistance. For example,

Uber Health has partnered with an IT vendor,

Cerner, in six states to get clients to and

from their medical appointments. Lyft is also

designated as a covered option for providing

rides for eligible Medicaid beneficiaries.53

• Combined healthcare visits - Combining HIV

care and other healthcare needs (e.g., routine

check-up, behavioral health services) in one

visit can limit the number of times a client needs

to visit their healthcare provider, especially in

settings where significant travel may be needed

to attend appointments.54 Practitioners should

clarify if adequate reimbursement for these visits

is available by confirming whether third party

payers have the capacity to reimburse for sameday services.

• Mobile health programs - Mobile health

programs have been used successfully to

increase HIV screening among high-incidence

populations in underserved areas.55 Many

syringe services programs (SSPs) utilize

mobile sites due to their flexibility to respond

to changing client needs and ability to provide

a more informal, easily accessible location for

clients who are unable to travel to a fixed site.56

• Outreach - Outreach activities, commonly used

to link and retain people with HIV in care,

can reduce barriers to accessing care. Patient

navigation models specifically emphasize

outreach, with navigation sessions often taking

place in community settings where clients 

may feel more comfortable than in a clinic 

environment.57 SSPs also expand their reach 

through secondary or peer-delivery models. 

SSPs provide people who inject drugs (PWID) 

with sterile injection drug use equipment to 

distribute to their networks and to inform them 

of disposal options.56

Financing

Challenge

Funding (including financing trainings, reimbursing staff, 

furnishing programs with needed materials) is essential 

to implementing and sustaining public health practices. 

Specific financing challenges for the recommended 

programs include: 

• Insurance reimbursements for services

• Sustainable federal and state funding for service

delivery not covered by insurance

• Restrictions on the use of federal funding for SSPs

• Lack of funding for reinforcers and vouchers

necessary for Contingency Management (CM)

• Lack of funding for highly experienced clinicians

to implement and facilitate programming

Strategies

Clinic administrators and leadership need to consider 

strategies for how to:

• Fund a practice

• Diversify funding streams across federal, state,

local, and private initiatives58

• Counteract cost-prohibitive challenges to

program implementation

When doing so, they should pay particular attention to:

• The specific resources available and needed

to implement HIV and mental illness and/

or SUD services, including number of staff,

additional costs related to program materials,

and anticipated duration of funding.58

• Potential collaborators that may have access to

alternative funding sources. Community-based

organizations, correctional facilities, community

health centers, or mental illness and/or SUD
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 37

treatment settings can act as partners when 

applying for grants that may only be accessible 

to specific types of organizations. Partnerships 

can also be a way to offset the cost of programrelated materials. 

− CM costs pose a unique challenge, as many 

state Medicaid, Medicare, and private 

insurance entities may not reimburse the 

reinforcers that are used in this practice, and 

programs are prohibited from reimbursing 

for more than $75 annually or $15 per individual appointment, regardless of the source 

of the funds. Additional funding sources, 

such as federal, state, and private grants, 

as well as contributions from or opportunities to share costs with partners, can help 

overcome barriers to funding CM reinforcers. SAMHSA suggests soliciting donations 

(which might prove particularly effective at 

providing CM reinforcers) and making use 

of volunteers or internships to cut costs.60

RYAN WHITE HIV/AIDS PROGRAM 

(RWHAP)

• RWHAP, a federal initiative started in 1990,

can act as the “payer of last resort” for people

with HIV, and be used to complete care for

uninsured and underinsured individuals (for

out of pocket costs, including medication

copays or co-insurance for office visits).

RWHAP complements and supplements

other health programs such as Medicaid and

commercial health insurance.

• RWHAP plays a critical role in improving

health outcomes for people with HIV across

the care continuum.

• This funding is only available for people with

HIV, leaving a gap in coverage for preventive

services.

• Each year over half a million people receive at

least one service under the program.

• RWHAP is the third largest source of federal

funding for HIV care in the United States,

following Medicare and Medicaid, and was

funded at $2.3 billion in FY 2019.59

Special Funding Considerations 

for SSPs

The Consolidated Appropriations Act of 2016 

allows the U.S. Department of Health and Human 

Services to fund SSP education and program 

evaluation.66 Importantly, this legislation, as well 

as subsequent congressional appropriations 

acts, states that federal funds cannot be used to 

purchase needles or syringes.67-68

• How the practice aligns with federal-level

priorities and funding opportunities.

• The “Ending the HIV Epidemic: A Plan for

America” initiative allocated $716 million in

fiscal year (FY) 2021 to preventing, diagnosing,

treating, and responding to HIV.61

• Potential insurance reimbursement strategies.

− PrEP is included in Grade A preventive interventions by the U.S. Preventive Services 

Task Force. Therefore, most insurance plans 

are required to cover prescriptions for PrEP 

at no cost to the client. However, the task 

force recommendation does not extend to 

lab tests or other clinical services.62

o The Centers for Medicare & Medicaid

Services offer grant funding to reimburse 

patient navigators.63

• Opportunities to expand the types of trained

facilitators leading behavioral health

interventions, such as CBT and CM. Tapping

graduate students and psychology or social work

interns to facilitate these programs under clinical

supervision can offset program costs as these

practitioners are generally not paid.64-65
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 38

Practice Resources

Practices to Increase Uptake of and Improve 

Adherence to PrEP

• The AETC’s “Prescribing PrEP for HIV

Prevention: A Guide for Medical Providers” is

a “pocket-guide” for practitioners considering

prescribing PrEP. It includes an ideal timeline

for screenings and visits, billing codes, and

information about potential side effects.69

• The Harford County Health Department PrEP

Resource Binder70 and Michigan Department

of Health & Human Services PrEP Provider

Toolkit71 are resources for providers (e.g.,

CDC consultation, prescribing guidelines, and

summaries of PrEP efficacy trials) and clients

considering PrEP (e.g., FAQs).

• The Fenway Institute’s Implementing PrEP

for HIV Prevention: State-wide Initiative and

Provider Experiences presentation focuses

on state-wide implementations of PrEP,

provider feedback and experiences, and health

communication materials to promote PrEP

uptake.72

Syringe Services Programs (SSPs)

• The Harm Reduction Coalition Capacity Building

Services provides free mentoring, training,

and technical assistance, including the HIV

Harm Reduction Navigator Core Competency

Training and Skills-Building Training, to health

departments, community-based organizations,

and other community stakeholders seeking to

establish, expand, or improve the effectiveness of

their SSPs.73

• The CDC’s Capacity Building Assistance

Provider Network provides free training

and technical assistance, continuous quality

improvement, and marketing and administrative

support for health departments, communitybased organizations, and community partners

looking to implement or improve HIV

prevention programs and services.74

• The Harm Reduction Coalition’s Guide to

Developing and Managing Syringe Access

Programs provides an overview of harm reduction

principles and guidance on how to develop,

implement, and manage a SSP.75

• The National Alliance of State and Territorial

AIDS Directors (NASTAD) and Urban Coalition

for HIV/AIDS Prevention Services (UCHAPS)
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 39

Syringe Services Programs (SSP) Development 

and Implementation Guidelines for State and 

Local Health Departments provides guidance 

on several aspects of SSP implementation, 

including how to conduct a community needs 

assessment, select a service delivery model, 

monitor outcomes, and build capacity of 

program staff.56

• Comer Family Foundation’s Guide to Establishing

Syringe Services Programs in Rural, At-Risk

Areas provides an overview of the importance

of SSPs in fighting the opioid epidemic. This

resource offers guidance on considerations for SSP

implementation and case studies of rural SSPs.76

• Oregon Health Authority Harm Reduction and

SSP Planning Manual and Resource Library

offers a manual and several resources on SSP

planning and implementation.77

Contingency Management

• Contingency Management: Using Motivational

Incentives to Improve Drug Abuse Treatment

provides an overview of CM principles, a case

study of a program using CM, and guidance

regarding how to implement and supervise CM

procedures.78

• The UCLA Integrated Substance Abuse

Program’s A Treatment Manual for

Implementing Contingency Management: Using

Incentives to Improve Parolee Enrollment and

Attendance in Community Treatment is a guide

for implementing CM for SUD treatment among

parolees.79

• The Behavioral Health Recovery Management

project A Clinician’s Guide for Implementing

Contingency Management Programs provides

step-by-step guidance on CM implementation.80

Cognitive Behavioral Therapy

• National Association of Cognitive Behavioral

Therapists CBT Onsite Training provides

multiple resources for both administrators and

clients, training, and certification for CBT

administrators (i.e., professionals, educators,

graduate students).81

• Beck Academy CBT training and certification

offers training and certification for CBT

administrators (i.e., professionals, educators,

graduate students), online and in-person training

courses, newsletters, assistance with program 

implementation, and information on utilizing 

supervisors and consultants.82

• The Evidence-Based Practice

Institute’s Intersecting Epidemics: Evidenced

Based Approaches for Treating Depression

and HIV/AIDS is an on-demand course (paid

access), including a video recording, slides, and

handouts.83

• Massachusetts General Hospital offers an online

CBT program led by clinical experts (through

paid access) for practitioners, including live

chats with faculty and interactive discussion

boards.84

Patient Navigation

• Texas Institute for Excellence in Mental Health

Peer Specialist Training and Certification

Programs: A National Overview is a compilation

of information on existing peer specialist

training and certification programs in the United

States.85

• Best Practices for Integrating Peer Navigators

into HIV Models of Care is an AIDS United

publication that provides findings and lessons

learned from diverse peer navigation models and

grantee types.86

• As part of the National Minority AIDS Council’s

Organizational Effectiveness Series: Building

Healthy Organizations, HIV Navigation

Services: A Guide to Peer and Patient

Navigation Programs provides information

and tools to use in planning and implementing

patient navigation programs.87

• The Peer Assisted Treatment of HIV and

Substance (PATHS) Model guide describes the

development, implementation, and evaluation

of a navigation program that incorporates peers

into a substance use treatment program for

people with HIV.88

• Rural Health Information Hub’s Rural HIV/

AIDS Prevention and Treatment Toolkit

contains resources and information focused

on developing, implementing, evaluating, and

sustaining rural HIV/AIDS programs, including

a patient navigation model.89
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Guidance for Selecting and Implementing Evidence-based Practices 40

1 Veniegas, R. C., Kao, U. H., & Rosales, R. 

(2009). Adapting HIV prevention evidence-based 

interventions in practice settings: An interview 

study. Implementation Science, 4(1), 76. https://doi.

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2 Kegeles, S. M., Rebchook, G., Tebbetts, S., Arnold, 

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4 Centers for Disease Control and Prevention. (2018, 

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eval/logicmodels/index.htm

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QAI.0b013e3181605df1

6 Amodeo, M., Lundgren, L., Cohen, A., Rose, 

D., Chassler, D., Beltrame, C., & D’ippolito, M. 

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7 Cohen, A., Lundgren, L., Amodeo, M., Chassler, 

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recordingredirect.cgi/id/39706

8 Substance Abuse and Mental Health Services 

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Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 46

4

CHAPTER

Examples of Effective 

Programs and 

Strategies

The chapter describes how practitioners have 

implemented three prevention and treatment programs as 

part of a comprehensive strategy to prevent and treat HIV 

among people living with mental illness and/or substance 

use disorders (SUD):

•	 Faster Paths to Treatment: a SUD bridge clinic 

program implementing practices to Increase 

Uptake and Improve Adherence to Pre-Exposure 

Prophylaxis (PrEP)

•	 Louisville Metro Syringe Exchange Program 

(LMSEP): a Syringe Services Program (SSP)

•	 The Alexis Project: a HIV linkage and retention 

program implementing both Contingency 

Management (CM) and Patient Navigation

The three examples highlighted in this chapter were 

identified through an environmental scan and in 

consultation with experts. While there are additional 

programs that could have been featured in this chapter, 

those highlighted below were included to provide diverse 

examples of settings in which HIV and mental illness and/

or SUD can be addressed. 

To be included, the interventions had to: 

•	 Include one or more of the practices identified in 

Chapter 2

•	 Be replicable (well-defined with guidance 

materials or a manual)

•	 Have research to support their impact on HIV 

and mental illness and/or SUD, or be identified 

as a promising practice

•	 Provide appropriate and effective interventions 

for varied geographic areas, practice settings, 

and diverse populations

Programs should implement practices with fidelity to 

evaluated models. Fidelity is the degree to which a 

program delivers a practice as intended and must be 

maintained for desired therapy outcomes. However, many 

programs adapt chosen practices to better serve their 

clients. As practitioners modify practices to address the 

needs and constraints of their population, budget, setting, 

and other local factors, they should strive to adhere to the 

practice’s foundational principles.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 47

Faster Paths to Treatment is a low-barrier SUD bridge 

clinic that opened in 2016 to address the opioid use 

disorder (OUD) epidemic and overdose crisis. It is part 

of a network of SUD treatment programs at Boston 

Medical Center, and it uses a flexible, client-centered, 

harm-reduction model to provide rapid access to 

medications for OUD, outpatient medically-managed 

withdrawal, overdose and HIV prevention services, 

sexually transmitted infection testing and treatment, 

and linkage to long-term SUD treatment and primary/

psychiatric care after stabilization. Faster Paths serves 

a population with high rates of prior drug overdose, 

polysubstance use, and homelessness. It is funded by the 

Massachusetts Department of Public Health Bureau of 

Substance Addiction Services. 

Model Features and Elements

Recognizing the need for on-demand services, Faster 

Paths offers both scheduled and walk-in appointments 

and aims to provide same day access to buprenorphine 

(a form of medication for opioid use disorder) and HIV 

prevention services including testing, PrEP, and postexposure prophylaxis (PEP). Same day services mitigate 

the chance of loss to follow-up and support client 

engagement. 

Evidence-Based Practice Implemented 

by the Program 

Practices to increase uptake of and improve 

adherence to PrEP

Population of Focus

People who use substances; 66 percent of clinic 

clients report injection drug behavior. Many clients 

have co-occurring psychiatric disorders and face 

significant psychosocial barriers to care, including 

housing instability. 

Approximate Time Period (Duration)

Clients are typically followed in Faster Paths for 

weeks to months

Related Resources

Program Website

Taylor, J. L., Walley, A. Y., & Bazzi, A. R. (2019). 

Stuck in the window with you: HIV exposure 

prophylaxis in the highest risk people who inject 

drugs. Substance Abuse, 40(4), 441-443. https://

pubmed.ncbi.nlm.nih.gov/31644387/

eReview of PrEP in PWID

Faster Paths to Treatment

Boston Medical Center (Boston, MA)

Findings and Outcomes

•	 Because Faster Paths clients often report recent 

potential HIV exposures, “PEP-to-PrEP” 

(starting on PEP and transitioning to PrEP) has 

been the safest, most efficient, and effective 

way to start PrEP for this population.1

 If a client 

reports being exposed to HIV within the last 72 

hours, Faster Paths emphasizes PEP as a bridge 

to PrEP, which can be started immediately at 

the end of a 28-day PEP course in clients who 

remain HIV negative. In April 2020, 22 percent 

of provider visit notes (including initial visits 

and follow up visits) addressed PEP or PrEP. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 48

•	 To support practitioners in consistently 

evaluating HIV prevention needs, Faster Paths 

has a standardized intake laboratory panel and 

electronic medical record note templates to 

assess risk of getting HIV and PrEP eligibility.

Lessons 

Learned 

•	 Many clients seen in Faster Paths have limited 

awareness about PrEP and its potential benefits 

as a result of not having had the opportunity 

to discuss PrEP with a provider in the past, 

limited information about PrEP within their 

social network, and marketing that has not been 

inclusive of people who inject drugs (PWID). 

•	 The way a provider discusses PrEP can 

be crucial for uptake. For example, it can 

be important to emphasize that PrEP is 

recommended for preventing HIV for a wide 

range of populations (e.g., PWID, men who 

have sex with men, and heterosexual people) to 

reduce stigma related to PrEP.

•	 Faster Paths aims to educate clients about PrEP 

in a manner that is not overwhelming (e.g., at 

initial or follow-up visits, depending on client 

preference), highlighting the ways PrEP can 

benefit both the client and their networks (i.e., 

sexual and injection drug use equipment–sharing 

partners), and emphasizing that PrEP will not 

necessarily be a life-long medication. 

•	 Faster Paths clients have an increased likelihood 

of acute HIV disease due to a current outbreak 

among PWID in Boston, MA. In April, 2020, 13 

percent of HIV screening tests in Faster Paths 

resulted in a new diagnosis of HIV transmission 

associated with injection drug use. Providers 

have expressed concern about starting sameday PrEP while awaiting HIV test results due 

to potential barriers to reaching the client to 

stop PrEP if the test returns positive. However, 

providers realized when they asked the client to 

return to the clinic to begin PrEP at a later date, 

opportunities were missed due to loss to followup. Therefore, if a client has a reliable method of 

contact, providers consider starting PrEP while 

HIV test results are pending. 

•	 Many SUD providers were not educated about 

PEP/PrEP during their clinical training, and 

the PEP/PrEP cases seen in Faster Paths are 

complex. To increase provider confidence 

prescribing PEP/PrEP in PWID, Faster Paths 

conducts didactic sessions with faculty, nurses, 

fellows, licensed drug and alcohol counselors, 

and administrative staff and provides real-time 

clinical support when PEP/PrEP questions arise. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 49

The Louisville Metro Syringe Exchange Program 

(LMSEP) is a SSP that started in 2015. Established 

through the Louisville Department of Public Health and 

Wellness, LMSEP has two main goals: 

•	 Prevent the spread of blood-borne infectious 

diseases transmitted through syringe sharing

•	 Link PWID to treatment 

As a harm reduction program, LMSEP works with 

numerous community organizations and stakeholders to 

provide the following to PWID in the Louisville Metro 

area: 

•	 Access to free and sterile syringes

•	 Safe syringe disposal (on site and at two mailbox 

disposals in the community)

•	 Fentanyl test strips

•	 Safe injection supplies

•	 HIV and hepatitis C virus (HCV) testing and 

referrals

•	 Referrals for mental illness and/or SUD 

treatment

•	 Counseling

•	 Harm reduction education on HCV, HIV, 

sexually transmitted infections, wound care, 

and overdose prevention (including providing 

naloxone)

LMSEP offers syringe exchange services at their main 

site inside the Louisville Metro Department of Public 

Health and Wellness. In addition, they offer mobile van 

exchange services at seven satellite locations during the 

week. 

Model Features and Elements

•	 The primary pillar of LMSEP is trust. Through 

its outreach work, LMSEP emphasizes 

accepting participants where they are and not 

judging them or stigmatizing them further. 

Staff and volunteers also tell participants that 

pursuing SUD treatment is voluntary and not a 

requirement of the program.

•	 Underscoring the importance of mutual respect 

between participants and staff, LMSEP created 

Evidence-based Practice Implemented 

by the Program 

Syringe Services Program (SSP) 

LMSEP is an outpatient SSP organized by the 

Louisville Department of Public Health and 

Wellness. LMSEP offers social and health 

services to PWID through fixed-site and mobile 

van settings. 

Population of Focus

PWID, specifically adults aged 18 to 25.

Approximate Time Period (Duration) 

Indefinite 

Related Resources

• Program Website

• LMSEP Overview (slides)

• LMSEP Brochure of Services

• LMSEP Guidelines

• LMSEP Research Brief

Louisville Metro Syringe Exchange Program (LMSEP)

Louisville Metro Department of Public Health and Wellness (Louisville, KY)

a Participant Bill of Rights and Responsibilities 

to ensure the rights and expectations of 

participants, staff, and volunteers are clear to all 

individuals involved with the program. 

•	 During their first visit, participants are asked 

to complete a voluntary intake form. Using the 

Program Staff Check List and this intake form, 

staff discuss LMSEP’s numerous harm reduction 

and treatment services with participants.

•	 Within LMSEP’s harm reduction model, 

certified alcohol and SUD counselors and 

HIV prevention specialists provide onsite 

support, testing, and linkage. LMSEP staff 

link participants who test positive for HIV to 

a Kentucky Care Coordination program case 

manager at the University of Louisville to 

facilitate HIV-specific care and treatment. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 50

Findings and Outcomes

• Since its establishment in 2015, LMSEP has served 

more than 20,000 unique participants, has had 

about 115,000 visits, and has distributed more than 

five million sterile syringes. LMSEP has also:

− Tested more than 35,000 people for HIV and 

referred 29 for treatment

− Tested more than 4,800 people for HCV and 

referred approximately 700 for treatment

− Referred 719 people for SUD treatment

− Connected more than 300 people to other 

community services

• Since LMSEP staff began distributing naloxone, 

890 participants have reported almost 2,000 

overdose reversals. 

• Louisville has prevented a substantial rise 

in new HIV diagnoses, reporting a stable 

transmission rate while neighboring states have 

experienced increases. Before LMSEP opened, 

the rate of new HIV diagnoses in the Louisville 

metropolitan region was 15.3 per 100,000 in 

2014. In 2017, the rate of new HIV diagnoses 

was 13.9 per 100,000.2

Lessons 

Learned 

•	 Less restrictive dispensation policies (e.g., 

providing the number of supplies a client reports 

needing instead of offering one set of sterile 

supplies for every one set of used supplies) reduce 

syringe re-use and may benefit people who use 

injection drugs and may not directly attend a SSP. 

•	 Build community collaboration and support to 

counter the stigma attached to the SSP practice. 

Engage partners from the start of program 

development throughout implementation. When 

assessing community readiness to start an SSP, 

LMSEP worked to build support with various 

partners and stakeholders, including political 

and social leaders, healthcare and social services 

providers, law enforcement, neighborhood 

associations, business owners, fire and rescue 

departments, the local media, and district and 

county attorneys. 

•	 Building trust with program participants is 

often difficult but especially important. In 

LMSEP, this trust facilitated an increase of 

immunizations and treatment during a hepatitis 

A outbreak and the ability to educate participants 

on COVID-19 health and safety issues.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 51

Evidence-based Practice Implemented 

by the Program 

Contingency Management (CM), Peer Health 

Navigation (PHN) 

Friends Community Center is a non-clinical 

community research center that collaborates with 

two medical clinics that provide HIV primary care.

Population of Focus

Transgender women of color with HIV

Approximate Time Period (Duration)

18 months

Resources on the Program

• Program Website

• Alexis Project Implementation Manual 

• SPNS Initiative: Enhancing Engagement and 

Retention in Quality HIV Care for Transgender 

Women of Color, 2012-2017 background 

• Reback, C.J., Kisler, K.A., & Fletcher, J.B. 

(2019). A novel adaptation of peer health 

navigation and contingency management for 

advancement along the HIV care continuum 

among transgender women of color. AIDS and 

Behavior. https://doi.org/10.1007/s10461-019-

02554-0 

The Alexis Project was developed under the Enhancing 

Engagement and Retention in Quality HIV Care for 

Transgender Women of Color Initiative funded by the 

Health Resources and Services Administration’s (HRSA) 

Special Programs of National Significance (SPNS). 

The project utilizes a multi-tiered approach to identify, 

engage, and retain in care transgender women of color 

with HIV.

The Alexis Project is named after Alexis Rivera 

who died on March 28, 2012, at the age of 34, from 

complications related to HIV. She was a proud Latina 

transgender woman, community activist, and peer 

advocate. 

Model Features and Elements

The Alexis Project incorporates social network 

recruitment and engagement, peer health navigation, and 

contingency management to promote achievement of 

health outcomes along the HIV care continuum. Through 

social network recruitment, the Alexis Project recruits 

transgender women of color, who know they have 

HIV but are not in care, to the combined peer health 

navigation and contingency management intervention. 

Peer Health Navigation (PHN): 

•	 Peer health navigators work with participants 

to develop a client-centered treatment plan 

and link them to HIV care and/or other needed 

services (e.g., hormone therapy, mental health 

counseling, substance use treatment, legal 

services, transportation assistance).

•	 Participants receive unlimited PHN sessions and 

can contact peer health navigators any time.

•	 Participants complete a needs and barriers 

assessment at each session.

•	 The goals of sessions are to: 

− Identify barriers to care,

− Identify and link participants to needed 

services, and

− Increase participants’ self-efficacy in working with HIV care providers and other treatment facilities.

•	 Participants receive increasingly valuable 

reinforcers in the form of CM reward points, 

which are redeemable for goods or services 

that promote a healthy, prosocial lifestyle (e.g., 

gift cards, bus tickets, payment of a utility bill, 

clothing). 

•	 Increasingly valuable reinforcers serve as 

motivators for HIV care-seeking behavior and 

are specifically awarded to participants for 

attending HIV care visits and reaching and 

maintaining HIV milestones. 

The Alexis Project

Friends Community Center, a Division of Friends Research Institute (Los Angeles County, CA) 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 52

Findings and Outcomes

•	 Combined PHN and CM intervention was 

found to be effective in linking and retaining 

transgender women of color in HIV care. 

•	 Average time from enrollment to linkage with 

HIV care was 67 days. 

•	 88 percent of participants attended at least two 

PHN sessions.

•	 85 percent of participants attended a first HIV 

care visit, and 57 percent returned for a second 

HIV care visit.

•	 14 percent of participants escalated through 

the entire CM schedule to achieve undetectable 

status.

•	 At intervention completion, 85 percent of 

participants were linked to care, and 44 percent 

had achieved and/or maintained viral load 

suppression. 

•	 Increased attendance at PHN sessions was 

associated with increased probability of 

achieving behavioral and biomedical CM 

targets.

Lessons 

Learned 

•	 Program administrators should support patient 

health navigators in setting boundaries to 

prevent burnout and vicarious trauma. Patient 

health navigators should receive ongoing 

training and support.

•	 Implementation teams will need to train HIV 

clinics on providing culturally competent health 

care to transgender women of color. 

•	 Programs can promote retention in HIV care 

by providing unlimited PHN sessions, linking 

participants to other needed services, and 

providing an increasingly valuable reward 

schedule based on advancement through the HIV 

care continuum.

•	 PHN can be time consuming; for some 

participants, it may take multiple PHN sessions 

to feel ready to make a behavioral change. PHN 

should adopt a client-centered approach and 

build relationships first to develop a trusting 

partnership that facilitates lasting change for the 

client. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 53

Coordination of Mental Health and HIV Care in a Mental Health Setting 

Each of the case examples in this chapter illustrates how organizations have implemented one or more 

evidence-based practices in a clinical or community setting. While none of these examples highlights a program 

that is primarily focused on mental health, it is critical that programs primarily serving people with mental illness 

assess their clients for HIV risk, conduct HIV testing, and provide appropriate and integrated HIV prevention and 

treatment services and mental health treatment to address their client’s complex needs.3

When first working with a potential client, mental health providers can conduct an intake and/or mental health 

assessment using screening tools such as the brief measure for assessing generalized anxiety disorder (GAD7)4

 or the major depressive disorder module of the Patient Health Questionnaire (PHQ-9).5 During this intake 

and screening, a mental health provider has an opportunity to discuss a client’s overall health and wellbeing, 

including co-occurring medical conditions such as HIV. 

•	 If a client has not had a recent HIV test, mental health providers can supply a self-administered oral fluids 

test which can provide results within 20 minutes. 

− If a client does not have HIV, a mental health provider can provide PrEP education, and support 

PrEP uptake and adherence (as described in Chapter 2); PrEP is highly effective in preventing HIV 

transmission from condomless sex and injection drug use. 

− If a client has HIV, a mental health provider can link a client to HIV primary care treatment, and provide 

the counseling necessary to support client mental health and ART uptake and adherence (including 

Cognitive Behavioral Therapy, as described in Chapter 2). 

•	 For clients at risk for or with HIV, mental health providers can also connect the client to case management to 

address a client’s unmet ancillary needs (e.g., housing, employment, transportation), which will help reduce 

barriers to PrEP and ART adherence.

Integrated behavioral health and infectious disease care can facilitate rapid screening, testing, and treatment, 

and improve health outcomes for people experiencing mental disorders and HIV. One example of effective 

mental health and HIV service integration is an infectious disease psychiatric consultation service embedded 

within the infectious disease outpatient department in a Boston hospital. Participants were offered a 

comprehensive approach to depression care that included pharmacologic and ancillary psychological therapies. 

When psychiatric consultation services were offered and linked to primary care, participants experienced 

benefits to both their mental health and HIV-related health outcomes. Participants had a statistically significant 

reduction in depression and viral load, and statistically significant increase in CD4 count. Additionally, a greater 

number of participants were prescribed anti-depressants and stimulants to treat their depression.6
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Examples of Effective Programs and Strategies 54

1 Taylor, J. L., Walley, A. Y., & Bazzi, A. R. (2019). 

Stuck in the window with you: HIV exposure 

prophylaxis in the highest risk people who inject 

drugs. Substance Abuse, 40(4), 441-443. https://doi.

org/10.1080/08897077.2019.1675118

2 Moyer, S. (2019, December 12). Louisville’s 

syringe exchange - preventing HIV transmission 

while pointing to recovery. Kentuckiana Health 

Collaborative. https://www.khcollaborative.

org/2019/12/louisvilles-syringe-exchange-2/

3

 Chuah, F., Haldane, V. E., Cervero-Liceras, F., 

Ong, S. E., Sigfrid, L. A., Murphy, G., Watt, N., 

Balabanova, D., Hogarth, S., Maimaris, W., Otero, 

L., Buse, K., McKee, M., Piot, P., Perel, P., & 

Legido-Quigley, H. (2017). Interventions and 

approaches to integrating HIV and mental health 

services: a systematic review. Health policy and 

planning, 32(suppl_4), iv27–iv47. https://doi.

org/10.1093/heapol/czw169

Reference List

4

 Spitzer, R. L., Kroenke, K., Williams, J. B. W., & 

Löwe, B. (2006). The brief measure for assessing 

generalized anxiety disorder: The GAD-7. Archives 

of Internal Medicine, 166(10), 1092-1097. https://

doi.org/10.1001/archinte.166.10.1092

5 Patient Health Questionnaire (PHQ-9). https://www.

med.umich.edu/1info/FHP/practiceguides/depress/

phq-9.pdf

6

 Coleman, S. M., Blashill, A. J., Gandhi, R. 

T., Safren, S. A., & Freudenreich, O. (2012). 

Impact of integrated and measurement-based 

depression care: clinical experience in an HIV 

clinic. Psychosomatics, 53(1), 51–57. https://doi.

org/10.1016/j.psym.2011.07.004
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Resources for Evaluation and Quality Improvement 55

5

CHAPTER

Resources for 

Evaluation and Quality 

Improvement

Evaluating a practice or program answers critical 

questions about how well a practice has been 

implemented, and what is and is not working. Evaluation 

can also show how clients benefit from a program. 

This information can be helpful in making program 

adjustments, if necessary, and demonstrating the value 

of a program or practice to justify its continuation and 

secure additional funding. In addition, stakeholders 

can use information gathered through evaluation to 

encourage implementation of that practice in other 

programs or communities. 

This chapter provides an overview of approaches to 

evaluate implementation of and results from practices to 

prevent and treat human immunodeficiency virus (HIV) 

among people with mental illness and/or substance use 

disorders (SUD). 

This chapter also includes information on implementing 

a continuous quality improvement (CQI) process. 

Finally, the chapter concludes with specific evaluation 

resources, including potential outcomes to track. 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Resources for Evaluation and Quality Improvement 56

Types of Evaluations 

Evaluation is typically conducted before a practice is implemented to determine its feasibility (formative evaluation), 

during implementation (process evaluation and CQI), and after the intervention has been delivered to at least one client 

(outcome and impact evaluations). Each type of evaluation is necessary to assess an intervention’s effectiveness. The 

graphic below illustrates these evaluation types in greater detail.

CONTINUOUS QUALITY IMPROVEMENT (CQI)

What is CQI?

CQI involves a systematic process of assessing program or practice implementation and short-term outcomes and 

then involving program staff in identifying and implementing improvements in service delivery and organizational 

systems to achieve better treatment outcomes. CQI helps assess practice fidelity, the degree to which a program 

delivers a practice as intended. There are many potential CQI models and approaches (see e.g., https://www.

healthit.gov/faq/what-are-leading-continuous-quality-improvement-strategies-health-care-settings).

CQI differs from process evaluation in that it involves quick assessments of program performance, timely 

identification of problems and potential solutions, and implementation of small improvements to enhance 

treatment quality. CQI is usually conducted by internal staff. Process evaluation involves longer-term 

assessments and is best conducted by an external evaluator. 

The Network for Improvement of Addiction Treatment (NIATx), a project originally funded by SAMHSA’s Center 

for Substance Abuse Treatment, offers tools to conduct CQI and improve services in substance use disorder 

treatment settings. NIATx is based on the principle of program improvement through a series of small changes, 

tested and implemented one at a time, that in the end have a cumulative effect.

The Institute for Healthcare Improvement’s PDSA Model for Improvement identifies a scientific method for 

testing small-scale changes in an action-oriented, cyclical manner. The stages are: planning it (Plan), trying it 

(Do), observing the results (Study), and acting on what is learned (Act).

Why use CQI? 

CQI takes a broader look at the systems in which programs or practices operate. Because of the pivotal role it 

plays in performance management, organizations preventing and treating HIV among people with mental illness 

and/or substance use disorders are encouraged to implement CQI procedures. 

What are the steps involved in CQI?

Although steps in the CQI process may vary based on objectives, typical CQI 

steps are:

• Identify a program or practice issue needing improvement and a target 

improvement goal

• Analyze the issue and its root causes

• Develop an action plan to correct the root causes of the problem, including 

specific actions to be taken

• Implement the actions in the action plan

• Review the results to confirm that the issue and its root causes have been 

addressed and short-term and long-term treatment outcomes have improved

• Repeat these steps to identify and address other issues as they arise

Institute for Healthcare Improvement. (n.d.). Science of improvement: Testing changes. http://www.ihi.org/resources/Pages/HowtoImprove/ScienceofImprovementTestingChanges.aspx

New Jersey Department of Children and Families. (n.d.). Five Stages of Continuous Quality Improvement. https://www.nj.gov/dcf/about/divisions/opma/CQI%20framework.pdf

University of Wisconsin-Madison, NIATx National Program Office. (n.d.). What is NIATx? https://www.niatx.net/what-is-niatx/ 

U.S. Department of Health & Human Services Office of Adolescent Health. (n.d.). Continuous Quality Improvement, Part 1: Basics for Pregnancy Assistance Fund Programs. 

https://www.hhs.gov/ash/oah/sites/default/files/cqi-intro.pdf
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Resources for Evaluation and Quality Improvement 57

Preparing to Collect Data

The following steps can help clinics and practitioners 

prepare to collect and analyze data:

1. Determine if the purpose of the data 

collection is evaluation or research. 

Qualitative and quantitative evaluation and 

research enables managers and clinicians to 

learn from clients and obtain the perspective of 

those with lived experiences. Both evaluation 

and research can also involve collecting data 

from staff who deliver the new treatment to 

obtain their perspectives on facilitators and 

challenges to practice implementation. 

Program evaluation supports program 

improvement. Research contributes to 

generalizable knowledge by implementing study 

protocols and procedures approved by Institutional 

Review Boards (IRB) that adhere to human 

subject research protections. When designing 

program evaluations, researchers should consult 

with their institutions to ensure they are following 

appropriate data collection procedures.

2. Identify team members to conduct evaluation 

activities. 

Regardless of the type of evaluation conducted, 

collecting and analyzing data takes time. 

Programs need to identify team members who 

can conduct evaluation activities and secure 

funding to protect their time for evaluation 

trainings, data collection, and data analysis. 

3. Determine outcomes of interest. 

A challenging step in the process of implementing 

new practices is to determine whether the practice 

has yielded desired outcomes. An outcome is the 

change a program hopes to accomplish through 

the implementation of a practice. 

Outcomes

The table below provides a list of potential outcomes, 

example outcome indicators, and qualitative and 

quantitative data sources that program managers, 

clinicians, and others may use to evaluate practices 

identified in Chapter 2. Some of the short- and 

intermediate-term outcomes may be tracked at baseline 

and throughout the practice or program duration through 

an electronic health record, or through interviews with 

staff and clients. Longer-term outcomes may be obtained 

from administrative and survey data.

Qualitative and quantitative data are 

complementary. Each provides critical insight 

into if and how the intervention is operating and 

achieving the intended objectives. 

Qualitative data include any non-numeric, 

text-based information, such as verbal, visual, 

or written data. Qualitative data collection 

methods include interviews, focus groups, clinical 

observations, gathering data from documents and 

images, and open-ended survey questions and 

polling responses. 

Quantitative data are any numeric data that 

can be processed by mathematical or statistical 

analysis. Quantitative data collection includes 

close-ended survey questions and polling 

responses, services and utilization data, and 

claims and encounter data.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Resources for Evaluation and Quality Improvement 58

Outcome Practice Illustrative Indicators Illustrative Data Sources

Short-term and intermediate outcomes

Engagement in 

services 

SSPs •	 Access to SSP (number of sites, 

hours open)

•	 Clients accessing SSP (visit numbers 

and dates)

•	 Syringes distributed and returned for 

disposal

•	 Qualitative interviews (staff and clients)

•	 Administrative data 

•	 Intake/enrollment data 

PrEP •	 Sessions and contacts scheduled and 

completed

•	 Administrative data 

CBT

CM

PN

HIV education CBT •	 Change in knowledge, motivation, and 

skills to engage in HIV preventive acts 

(e.g., condom attitudes and use), 

•	 Perceptions of personal vulnerability 

to HIV

•	 Qualitative interviews (staff and clients)

•	 Structured scales and assessments 

(e.g., Sexual Risk Behavior 

Assessment Schedule)

CM

PN

Knowledge of HIV 

and SUD harm 

reduction strategies

SSPs •	 Knowledge of safe injection practices 

•	 Knowledge about HIV transmission

•	 Knowledge of overdose prevention 

strategies (e.g., naloxone access and 

trainings) 

•	 Qualitative interviews (staff and clients)

•	 Structured scales and assessments

•	 Attendance/administrative data

•	 Number of naloxone trainings and 

naloxone kits distributed

CBT

PrEP uptake PrEP •	 Number of PrEP prescriptions 

provided and filled

•	 Medical records

•	 Pharmacy records

Linkage or relinkage to HIV careSSPs •	 Number of HIV linkage-to-care visits 

scheduled and completed

•	 Administrative records

CM •	 Medical records

PN

Injection drug use 

behaviors

SSPs •	 Injecting with a sterile syringe 

•	 Sharing injection equipment

•	 Qualitative interviews (clients)

•	 Staff logbooks 

•	 National Institute on Drug Abuse 

(NIDA) Risk Behavior Assessment

CBT

CM

Ancillary service 

delivery

SSPs •	 Referrals made and visits completed 

for specialty care and ancillary 

services (e.g., HIV/HCV/STI testing, 

medication-assisted treatment)

•	 Qualitative interviews (staff and client)

•	 Administrative data 

•	 Medical records 

PN

Retention in HIV 

care

CM •	 Number of medical visits that were at 

least 90 days apart (in the past year) 

•	 Qualitative interviews (clients)

PN •	 Medical records

Medication 

Adherence 

PrEP •	 Ongoing PrEP prescriptions provided 

and filled

•	 Medical records 

•	 Pharmacy records

CBT •	 ART prescriptions provided and filled •	 Qualitative interviews (client)

•	 Medical records

•	 Medication Event Monitoring Systems 

(MEMS)

CM

PN
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Resources for Evaluation and Quality Improvement 59

Outcome Practice Illustrative Indicators Illustrative Data Sources

Short-term and intermediate outcomes

Substance Use PN •	 SUD

•	 Days of substance use in the prior 30 

days

•	 Qualitative interviews (client)

•	 Urine drug screen

•	 Alcohol, Smoking, and Substance 

Involvement Screening Test (ASSIST)

•	 Alcohol Use Disorders Identification Test 

(AUDIT)

•	 Drug Abuse Screening Test (DAST-10)

Individual-level 

mental health

CBT •	 Mental health score •	 Structured scales and assessments 

(e.g., PHQ-9 for depression, Beck 

Depression Inventory, Hamilton 

Depression Scale, Montgomery-Asberg 

Depression Rating Scale, Generalized 

Anxiety Disorder (GAD-7) Scale) 

PN •	 12-item short form health survey (SF-12)

Changes in HIV risk 

associated with 

SUD

SSPs •	 Frequency of substance use

•	 Cessation of injection drug use 

•	 Qualitative interviews (staff and clients)

•	 NIDA Risk Behavior Assessment

Long-term and population-level outcomes and impacts

Individual-level HIV 

outcomes

CBT •	 CD4 cell count 

•	 Viral load

•	 Medical records

CM •	 Lab test/blood sample

PN

Population-level 

HIV outcomes 

SSPs •	 Rate of new HIV diagnoses

•	 Prevalence of HIV 

•	 Administrative data

PrEP •	 Medical records

CBT

CM

PN

 SSPs PrEP CBT CM PN

Evaluation Resources 

Evaluating Program Implementation

•	 A Framework for Program Evaluation, from the 

Program Performance and Evaluation Office at 

the Centers for Disease Control and Prevention, 

summarizes essential elements of program 

evaluation.

•	 The Community Toolbox, from the Center for 

Community Health and Development at the 

University of Kansas, includes a step-by-step 

guide to developing an evaluation of a community 

program, specific tools, and examples.

Quality Improvement and Continuous 

Performance Monitoring

•	 Institute for Healthcare Improvement’s Quality 

Improvement Essentials Toolkit includes the tools 

and templates to launch a quality improvement 

project and manage performance improvement.

Evaluating Practices Specifically Addressing 

HIV and Mental Illness and/or SUD

•	 The Center for Innovation in Social Work and 

Health Community Health Worker toolkit includes 

best practices for evaluating peer programs. 

•	 Rural Health Information Hub (RHIhub)

has created HIV, Mental Health, SUD, and 

Telehealth specific Evidence-Based Toolkits for 

Rural Community Health (that can be broadly 

applied to both rural and urban health).

•	 The National Minority AIDS Council created 

a guide to program evaluation as part of their 

Organizational Effectiveness Series, defining 

types of evaluation, ways to assemble an 

evaluation team and design an evaluation plan, 

and steps to conducting an evaluation.
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Appendix 1: Acknowledgments 60

This publication was developed with a significant contribution from Alexis Marbach, MPH, SAMHSA staff, a technical 

expert panel, and Abt Associates staff. The guidance is based on the thoughtful input of SAMHSA staff and the Expert Panel 

on the prevention and treatment of HIV among individuals experiencing co-occurring mental illness and/or substance use 

disorders (SUD) from October 2019 through August 2020. A series of guide development meetings was held virtually over a 

period of several months. Three expert panel meetings were convened during this time. 

Appendix 1: Acknowledgments 

SAMHSA Staff 

Fred Bamfo, DNP, MPH Center for Substance Abuse 

Treatment*

Christine Cichetti, National Mental Health and 

Substance Use Policy Laboratory

Thomas Clarke, PhD National Mental Health and 

Substance Use Policy Laboratory 

Amanda Doreson, MPA National Mental Health and 

Substance Use Policy Laboratory

Daniel Gallardo, MPH National Mental Health and 

Substance Use Policy Laboratory

Neeraj Gandotra, MD Chief Medical Officer*

Tanya Geiger, PhD, MPH National Mental Health and 

Substance Use Policy Laboratory*

Kirk James, MD Center for Substance Abuse Treatment

Donelle Johnson, PhD, MHSA National Mental Health 

and Substance Use Policy Laboratory*

Expert Panel 

Michael B. Blank, PhD University of Pennsylvania 

Perelman School of Medicine

Katie Biello, PhD, MPH Brown University School of 

Public Health, The Fenway Institute

Deb Bourne, MD, MSW San Francisco Health Network, 

San Francisco Department of Public Health

Redonna Chandler, PhD National Institute on Drug 

Abuse (NIDA)

Francine Cournous, MD Columbia University Mailman 

School of Public Health, Northeast/Caribbean AIDS 

Education and Training Center 

Carlos Del Rio, MD Emory University School of 

Medicine, Rollins School of Public Health. Principal 

Investigator, and Center for AIDS Research 

Antigone Dempsey, M.Ed Division of Policy and Data, 

HIV/AIDS Bureau, Health Resources and Services 

Administration (HRSA)

Traci Green, PhD, MSc, Opioid Policy Research 

Collaborative, Brandeis University

Douglas Krakower, MD Beth Israel Deaconess Medical 

Center, The Fenway Institute, and Harvard Medical 

School 

Conall O’Cleirigh, PhD Harvard Medical School, 

Massachusetts General Hospital

Melinda Tinsley, MA Division of Policy and Data, 

HIV/AIDS Bureau, Health Resources and Services 

Administration (HRSA)

Glenn Treisman, MD, PhD Johns Hopkins University 

School of Medicine

Contract Staff

Olivia Bacon, Abt Associates

Korrin Bishop, Korrin Bishop Writing & Editing

Yvonne Cristy, Abt Associates

Margaret Gwaltney, MBA Abt Associates*

Alexis V. Marbach, MPH, Abt Associates*

Nikitha Reddy, Abt Associates

Cayla D. Roby, MA, MPH, Abt Associates

Daniel Jefferson Smith, Abt Associates

Sarah Steverman, PhD, MSW Abt Associates*

Christopher Weiss, PhD Abt Associates

Elyse Yarmosky, LISCW, Abt Associates

*Members of Guide Planning Team
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Appendix 2: Evidence Review Methodology 61

The authors followed a rigorous, systematic evidence 

review process in the development of this guide. This 

appendix provides an overview of the evidence review 

methodology used to identify the ratings for the practices 

included in the guide: practices to increase uptake of and 

improve adherence to PrEP, syringe services programs, 

cognitive behavioral therapy, contingency management, 

and patient navigation. Reviewers, in coordination with 

SAMHSA and experts, conducted a four-step process to 

select practices, identify related studies, review and rate 

studies, and identify practice ratings.

Step 1: Practice Selection 

The authors identified these five practices after a review 

of the literature and in consultation with experts. In an 

effort to include interventions that would be most useful 

to those seeking to prevent and treat HIV among people 

with mental illness and/or substance use disorders (SUD), 

eligible practices were required to meet the following 

criteria for evidence review: 

•	 Be clearly defined and replicable 

•	 Address the target outcome of preventing and 

treating HIV among people who use substances 

and/or have mental health concerns 

•	 Be currently in use

•	 Have studies of their effectiveness

•	 Have accessible implementation and fidelity 

supports

At the conclusion of this step, SAMHSA and the guide’s 

Expert Panel reviewed the proposed practices identified 

by the authors and agreed on five for inclusion in the 

evidence review and rating process.

Step 2: Study 

Identification

Once the practices were selected, the reviewers conducted 

a comprehensive review of published research on these 

practices to identify studies of the selected practices. This 

review only included studies from eligible sources (i.e., 

peer reviewed journals and government reports) that avoid 

clear conflicts of interest. The reviewers documented all 

potential studies identified through the literature search.

The studies identified in the literature search varied in 

type and rigor, so the reviewers assessed them further for 

inclusion in the evidence review. To be eligible for review 

and study rating, research studies had to: 

•	 Employ a randomized or quasi-experimental 

design, or 

•	 Be a single sample pre-post design or 

an epidemiological study with a strong 

counterfactual—a study that analyzes what 

would have happened in the absence of the 

intervention. 

Literature reviews, descriptive studies, implementation 

studies, and meta-analyses were not included in the 

review, but were documented to provide context and 

identify implementation supports for the practices.

Additionally, to be eligible for further review and rating, 

studies had to:

•	 Be published or prepared in or after 2000

•	 Be a publicly available peer-reviewed paper or 

research report

•	 Be available in English

•	 Include at least one eligible outcome related to 

HIV prevention and/or treatment

•	 Have a comparison/control group that is 

treatment as usual or no/minimal intervention 

if using a randomized experimental or quasiexperimental design

Step 3: Study Review and 

Rating

Next, trained reviewers assessed each study to ensure 

the methodology was rigorous and therefore could 

demonstrate causation between the practice and the 

identified outcomes. Reviewers reviewed and documented 

each study to ensure that: 

•	 Experimental and comparison groups were 

statistically equivalent, with the only difference 

being that participants in the experimental 

group received the intervention and those in the 

comparison group received treatment as usual or 

no/minimal intervention 

Appendix 2: Evidence Review Methodology 
Prevention and Treatment of HIV Among People Living with Substance Use and/or Mental Disorders

Appendix 2: Evidence Review Methodology 62

•	 For randomized experiments with high attrition 

and for quasi-experimental designs, baseline 

equivalence was established between the 

treatment and comparison groups 

•	 For randomized experiments, randomization 

was not compromised. For example, ensuring 

that reassignment of treatment status, usually 

made to balance the distribution of background 

variables between treatment and control groups, 

did not occur.

•	 Study did not have any confounding factors 

(factors that affect the outcome but are not 

accounted for by the study)

•	 Missing data were addressed appropriately

− Imputation based on surrounding cases was 

considered valid 

− Complete case analysis was considered valid 

and accounted for as attrition 

− Using model with dummy for missing as a 

covariate was considered valid 

− Assuming all missing data points are either 

positive or negative was not considered 

valid 

− Regression-based imputation was considered valid; mean imputation was not considered valid.

•	 Outcome measures were reliable, valid, and 

collected consistently from all participants

•	 Valid statistical models were used to estimate 

impacts

•	 Practice demonstrated improved outcomes 

related to HIV prevention and treatment

Based on the study design and these study characteristics, 

reviewers gave each study a rating for causal impact. 

Reviewers used the following scoring metric for each 

study based on the eight factors above to determine if a 

study is rated:

•	 High support of causal evidence

•	 Moderate support of causal evidence

•	 Low support of causal evidence

Only randomized controlled trials, quasi-experimental 

designs, and epidemiological studies with a strong 

comparison were eligible to receive a high or moderate 

study rating. 

Step 4: Practice Rating

After all studies for a practice were assessed for these 

criteria, the reviewers gave each practice a rating

based on the number of studies with strong, moderate, 

or emerging support of causal impact. Causal impact is 

evidence demonstrating that an intervention causes, or 

is responsible for, the outcome measured in the study’s 

sample population. The practice was placed into one 

of the following categories based on the level of causal 

evidence of its studies:

•	 Strong Evidence: Causal impact demonstrated 

by at least two randomized controlled trials, 

quasi-experimental designs, or epidemiological 

studies with a high or moderate rating.

•	 Moderate Evidence: Causal impact 

demonstrated by at least one randomized 

controlled trial, quasi-experimental design, or 

epidemiological study with a high or moderate 

rating.

•	 Emerging Evidence: No study received a high 

or a moderate rating. The practice may have 

been evaluated with less rigorous studies (e.g., 

pre-post designs) that demonstrate an association 

between the practice and positive outcomes, but 

additional studies are needed to establish causal 

impact.

The four-step process described above resulted in 

identification and rating of the five practices. The rating 

given to each practice is intended to inform decision 

making about adoption of new practices or clinical or 

system enhancements that will improve health outcomes 

for people with or at risk for HIV with co-occurring 

mental illness and/or SUD.
Photos are for illustrative purposes only. 

Any person depicted in a photo is a model.

Publication No. PEP20-06-03-001

First released 2020

SAMHSA’s mission is to reduce the impact of substance abuse and mental illness on America’s communities.

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