A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women

NCT03768986 | Completed DMC

• 2 other identifiers: 19-018-1R01MD013550
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Testing; Women; Contingency Management

Outcome Measures

Primary Outcomes (2)

• HIV testing by clients

  HIV testing completion (i.e. having test completed) will be verified by the testing sites

  From date of intervention until date of documented HIV test, assessed up to 15 months

• Clinician knowledge

  Change in clinician knowledge will be measured through self-reports

  Baseline and immediately post-training

Secondary Outcomes (1)

• Clinician satisfaction with training

  Post-training, up to 1 month

Study Arms (2)

Treatment Group A

ACTIVE COMPARATOR

Standard referral for HIV testing and online HIV risk reduction training

Behavioral: Standard referral for HIV testing; Behavioral: Online risk reduction training

Treatment Group B

EXPERIMENTAL

Standard referral for HIV testing and online HIV risk reduction training plus reinforcement

Behavioral: Standard referral for HIV testing; Behavioral: Online risk reduction training; Behavioral: Reinforcement

Interventions

Standard referral for HIV testing BEHAVIORAL

Participants receive standard referral for HIV testing in the community.

Treatment Group A; Treatment Group B

Online risk reduction training BEHAVIORAL

Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them.

Treatment Group A; Treatment Group B

Reinforcement BEHAVIORAL

Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV

Treatment Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• \- planning to end employment at the agency within the next 3 months
• female
• identifies as African American/black or Latina/Hispanic OR is living in poverty based on the most recent year's federal poverty guidelines
• 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
• received a fourth-generation HIV test in the past 6 months
• HIV positive.

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Interventions

HIV Testing; Reinforcement Machine Learning

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Machine Learning; Artificial Intelligence; Algorithms; Mathematical Concepts

Study Officials

• Kristyn Zajac, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: February 4, 2019
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)