Clinical trial NCT06835751: Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania
Official title: Optimizing PrEP Among Women Who Use Drugs in Tanzania
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Mental Health
Substance Use (Drugs, Alcohol)
Keywords: HIV pre-exposure prophylaxis (PrEP)
Mental health
substance use
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP). Women who use drugs face a higher risk of HIV infection, but many do not start or continue PrEP due to barriers like stigma, mental health challenges, and lack of support.

The study will enroll 200 women who use drugs in Dar es Salaam, Tanzania. These women will be randomly assigned to one of three groups:

Motivational Interviewing for PrEP (MI-PrEP) Only - Women in this group will receive two one-hour counseling sessions focused on HIV prevention, PrEP education, and problem-solving to help the women start and continue using PrEP.

Common Elements Treatment Approach (CETA) + MI-PrEP - Women in this group will receive the same MI-PrEP counseling sessions plus additional mental health counseling (up to 14 sessions) tailored to the women's individual needs, addressing issues like depression, anxiety, trauma, and substance use.

Treatment as Usual (TAU) - Women in this group will receive basic information on PrEP, mental health, and harm reduction, along with optional referrals to PrEP or drug treatment clinics.

The study will evaluate feasibility of administering MI-PrEP and CETA+MI-PrEP and how well these interventions help women start and stay on PrEP, as well as the intervention's impact on mental health and drug use. Researchers will also interview participants and counselors to understand the participants and counselors experiences with the program.

The goal is to find effective ways to support PrEP use among women who use drugs and to develop a model that could be used in similar settings to reduce HIV risk. This pilot study is approved by ethics committees in the United States and Tanzania, and results will be shared with communities, policymakers, and researchers.

Detailed description: This study is a pilot clinical trial aiming to assess the feasibility and preliminary efficacy of two interventions designed to improve PrEP engagement among women who use drugs (WWUD) in Dar es Salaam, Tanzania. The trial will enroll 200 participants who will be randomly assigned to one of three study arms: Motivational Interviewing for PrEP (MI-PrEP) only, Common Elements Treatment Approach (CETA) + MI-PrEP, or Enhanced Treatment as Usual (TAU). The study will evaluate whether these interventions can enhance PrEP uptake and adherence, while also addressing mental health and substance use challenges common among WWUD.

WWUD in Tanzania are at a heightened risk of acquiring HIV due to intersecting vulnerabilities, including drug use, high-risk sexual behaviors, and gender-based disparities. Although PrEP is a proven HIV prevention method, uptake among this population remains low due to stigma, limited healthcare access, and co-occurring mental health conditions. To address these barriers, this pilot trial will implement and evaluate MI-PrEP, a brief intervention designed to enhance motivation for PrEP use, and CETA + MI-PrEP, a more intensive mental health intervention that combines MI-PrEP with a modular, trans-diagnostic therapy addressing depression, anxiety, trauma, and substance use.

The MI-PrEP intervention will consist of two one-hour counseling sessions providing PrEP education, motivation enhancement, and problem-solving strategies. Participants in the CETA + MI-PrEP arm will receive the same MI-PrEP sessions in addition to up to 14 weekly CETA sessions tailored to individual mental health and substance use needs. The TAU control group will receive PrEP education, mental health and substance use resources, and optional referrals to PrEP and harm reduction services. The primary outcomes of the study will be feasibility, PrEP uptake, and adherence at one and six months post-intervention. Secondary outcomes include changes in depression, anxiety, PTSD symptoms, substance use behaviors, and HIV risk behaviors.

Participants will complete baseline, one-month, and six-month follow-up assessments. Quantitative data will be collected through structured surveys, while qualitative data will be obtained from in-depth interviews with a subset of trial participants and intervention counselors. Thematic analysis will be used to assess intervention feasibility, fidelity, and perceived impact. Statistical analyses, including logistic regression and mixed-effects models, will evaluate intervention effects on PrEP uptake, adherence, and mental health outcomes.

Safety protocols will be implemented to assess and manage risks related to suicide, homicide, interpersonal violence, and overdose. Ethical approvals have been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Ethics Review Committee, and the National Institute for Medical Research in Tanzania. The study also involves a Community Advisory Board (CAB) composed of WWUD and a Study Advisory Board (SAB) including representatives from academia, civil society, government agencies as well as healthcare providers and WWUD to ensure ethical and community-informed implementation.

Findings from this pilot trial will inform scalable strategies to support PrEP uptake among WWUD and other key populations at high risk for HIV infection. The results will be disseminated through community meetings, scientific conferences, and peer-reviewed publications, contributing to improved HIV prevention programming for WWUD in Tanzania and beyond.

Eligibility criteria: Inclusion Criteria:

* Female sex
* 18 years or older
* Non-reactive or negative HIV test result
* Self-reported drug- or sex-related HIV risk behaviors in the past six months
* Hazardous or harmful opioid use in the past six months
* Meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (PHQ-9 \>= 9), anxiety (GAD-7 \>= 10), and/or PTSD (HTQ \>= 40)

Exclusion Criteria:

* Reactive or positive HIV test result
* Currently taking PrEP
* Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments
* Unable to provide informed consent

Primary outcomes:
measure: Number of participants who report PrEP initiation
timeFrame: At enrollment, 1 month post-treatment, 6 months post-treatment
Secondary outcomes:
measure: Depressive symptoms as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At enrollment, 1 month post-treatment, 6 months post-treatment
measure: General anxiety symptoms as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: At enrollment, 1 month post-treatment, 6 months post-treatment
measure: Post-traumatic stress disorder (PTSD) as assessed by the Harvard Trauma Questionnaire (HTQ)
timeFrame: At enrollment, 1 month post-treatment, 6 months post-treatment
measure: Substance use as assessed by the Alcohol, Smoking, and Substance Involvement Screening (ASSIST) Global Continuum of Illicit Drug Risk Score
timeFrame: At enrollment, 1 month post-treatment, and 6 months post-treatment
measure: Gender-based violence as assessed by the World Health Organization (WHO) Violence Against Women Instrument (VAWI)
timeFrame: At enrollment, 1 month post-treatment, 6 months post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Haneefa T Saleem, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: