Clinical trial NCT03768986: A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women
Official title: A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
HIV Testing
Women
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-12-07
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: African American and Latina women, as well as women living in poverty, are an identified health disparities population for HIV. Risks for HIV are compounded in this population when additional risk factors are present, including other sexually transmitted infections, intimate partner violence, substance use disorders, and homelessness or housing insecurity. Knowledge of one's HIV serostatus is key to linkage to care, improving HIV outcomes, and decreasing the spread of HIV. However, roughly a third of African American women and over half of Latina women have never been tested (CDC, 2016a). Barriers to testing include socioeconomical inequality, racial discrimination, low health literacy, and inadequate access to quality healthcare, among others. Novel methods for increasing HIV testing in this important health disparities group are greatly needed.

This study aims to test a reinforcement-based intervention to increase HIV testing and repeat testing among African American, Latina, and women living in poverty who have risk factors for HIV. We are partnering with multiple community-based organizations, several of which are non-traditional providers of HIV services (e.g., domestic violence agency, homeless shelter), to address systemic and structural issues that serve as barriers to testing. A primary aim is to evaluate the effectiveness of training community-based providers to deliver a reinforcement-based intervention for promoting HIV testing. In addition, we will compare standard referral services for HIV testing plus HIV risk reduction education to the same plus reinforcement for HIV testing (and repeat testing) using a randomized controlled trial with 334 participants. Women in both groups will be encouraged to seek HIV testing; be provided with the resources to do so (list of testing sites, bus passes if needed); and will receive basic education about HIV prevention using a widely available web-based resource (https://wwwn.cdc.gov/hivrisk/). Women in the reinforcement group will also be provided with $25 for undergoing an HIV test, with a $15 bonus if they have the test in the next 7 days ($40 total). During the next 12 months, they can receive an additional $25 for undergoing up to 2 more tests separated by 12 weeks, with $15 bonuses for each test completed within 7 days (+/- 7 days) of the scheduled date at 6- and 12-months post-initial test. It is hypothesized that the reinforcement intervention will result in greater proportions of women receiving an HIV test (and repeat HIV tests) compared to standard services.

In the proposed study, approximately 50 clinicians from our partner sites will be trained on both the non-reinforcement and reinforcement approaches to increasing HIV testing. Primary clinician outcomes are clinician knowledge and attitudes about HIV, testing, and reinforcement interventions. These will be assessed pre- and post-training and at 6-month intervals thereafter. A secondary outcome is clinician satisfaction with the training. Once clinicians are trained to competence, 334 women at our partner agencies will be randomized. Participants will be assessed at baseline and at 3-, 9-, and 15-month follow-ups. The primary outcome is objective reports of HIV testing, verified by testing centers. Secondary outcomes are HIV risk behaviors, test results, self-efficacy, client attitudes towards testing, and HIV knowledge. In addition, this study will include a careful analysis of costs of the reinforcement intervention to allow for estimates of its cost-effectiveness in increasing HIV testing.

The overall goal of this study is to determine whether a reinforcement intervention delivered by community providers is superior to standard referral procedures plus HIV education in increasing rates of HIV testing among women at the highest risk of HIV infection. A wide range of community partners that serve some of the highest risk groups of women were chosen to ensure highly generalizable results. If efficacious, the intervention has the potential for widespread adoption and implementation.


Eligibility criteria: Inclusion Criteria for Clinician Participants:

* \>6 months experience as a case manager, medical/nursing clinician or mental health/substance use therapist
* currently work with women at high risk for contracting HIV
* able to attend a training and participate in the evaluative components
* willing to conduct both standard HIV referral for testing and orientation to an online training and the same with reinforcement, depending on client's random assignment.

Exclusion Criteria for Clinician Participants

- planning to end employment at the agency within the next 3 months

Inclusion Criteria for Client Participants:

* female
* identifies as African American/black or Latina/Hispanic OR is living in poverty based on the most recent year's federal poverty guidelines
* 18 and older
* one or more high risk factors for HIV: intravenous drug use; or sexually active with past year partners with HIV or of unknown HIV status and no or inconsistent use of condoms
* English or Spanish speaking
* passes a quiz related to understanding the informed consent form
* has an address at which they expect to be able to receive mail and/or a phone to retrieve messages for the next 15 months

Exclusion Criteria for Client Participants:

* received a fourth-generation HIV test in the past 6 months
* HIV positive.

Primary outcomes:
measure: HIV testing by clients
timeFrame: From date of intervention until date of documented HIV test, assessed up to 15 months
measure: Clinician knowledge
timeFrame: Baseline and immediately post-training
Secondary outcomes:
measure: Clinician satisfaction with training
timeFrame: Post-training, up to 1 month
measure: HIV risk behaviors
timeFrame: Baseline and 3-month follow-up
measure: HIV Test Results
timeFrame: 15-month follow-up
measure: Client HIV knowledge
timeFrame: Baseline and 3-month follow-up
measure: HIV Risk Reduction Module Completion
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Kristyn Zajac, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: