HIVNCT03768986
A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women
A study testing Standard referral for HIV testing, Online risk reduction training and Reinforcement in people with HIV and HIV Testing, run by UConn Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, HIV Testing, Women
- What is being tested?
- Standard referral for HIV testing, Online risk reduction training and Reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
- female
- identifies as African American/black or Latina/Hispanic OR is living in poverty based on the most recent year's federal poverty guidelines
Show all 11Show fewer
- 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
Who cannot join
- planning to end employment at the agency within the next 3 months
- received a fourth-generation HIV test in the past 6 months
- HIV positive.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Standard referral for HIV testing, Online risk reduction training, Reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard referral for HIV testingBehavioural
Participants receive standard referral for HIV testing in the community.
Online risk reduction trainingBehavioural
Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them.
ReinforcementBehavioural
Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | Standard referral for HIV testing and online HIV risk reduction training Receives: 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 Receives: Behavioral: Standard referral for HIV testing; Behavioral: Online risk reduction training; Behavioral: Reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial HIV Testing by Clients
HIV testing completion following initial intervention.
Measured: From date of intervention until 6 month testing reminders.
Repeat HIV Testing After 6 Month Reminders
Whether the participant received an HIV test after receiving reminders for testing at 6 months post-initial intervention
Measured: 6 month post-baseline through 12 month post-baseline
Repeat HIV Testing After 12 Month Reminder
Whether the participant received an HIV test following the 12 month reminder to get tested
Measured: 12 month post-baseline to 15 month post-baseline
Centers for Disease Control and Prevention Evaluation Toolkit About Routine HIV Screenings in Health Care Settings: Provider Questionnaire
Assessment of providers' perspectives on barriers to HIV testing in their setting. Change in HIV testing attitudes among the clinician participants between pre- and post-training on the study intervention. Rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Items indicating more barriers to testing were reverse coded. Higher scores mean fewer perceived barriers to HIV testing. Scores are item means, so the range of possible scores is from 1 to 5.
Measured: Baseline measure (pre-training) was completed prior to training in the intervention. Training occurred in a single day. Follow-up (post-training) was collected immediately following the one day training on the study intervention.
The Perceived Attributes Scale - Relative Advantage Subscale
Change in mean total scores on attitudes about reinforcement interventions (the Relative Advantage subscale). This subscale of the Perceived Advantage Scale measures a staff members' perception of how a new intervention (in this case, a reward intervention) would impact their work. Rated on a scale from 1 (strongly disagree) to 7 (strongly agree). There were 7 items on this subscale and total scores (from the subscale) are summed and then averaged. The lowest possible total score and mean = 7 and the highest possible total score and mean = 49. A higher score means a more positive perceived impact.
Measured: Baseline measure (pre-training) was completed prior to training in the intervention. Training occurred in a single day. Follow-up (post-training) was collected immediately following the one day training on the study intervention.
Secondary outcomes (1)
Satisfaction With Training (Single Item)
Clinician participants rated how satisfied they were with the training they received using a single item ("In general, how satisfied are you with the training?") rated on a scale from 1 (minimum) to 7 (maximum). Higher values represent higher levels of satisfaction.
Measured: Assessed immediately following the single-day training on the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start4 Feb 2019
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Kristyn Zajac, UConn Health
- Investigators
- Kristyn Zajac, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768986
- Sponsor's protocol ID
- 19-018-1
- Other IDs
- R01MD013550
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2018
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women
- ClinicalTrials.gov ID
- NCT03768986
- Acronym / sponsor ID
- 19-018-1
- Conditions
- HIV, HIV Testing, Women, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 30 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Behavioral: Standard referral for HIV testing, Behavioral: Online risk reduction trainingStandard referral for HIV testing and online HIV risk reduction training |
| Treatment Group B | Experimental | Behavioral: Standard referral for HIV testing, Behavioral: Online risk reduction training, Behavioral: ReinforcementStandard referral for HIV testing and online HIV risk reduction training plus reinforcement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- >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.
- female
Key exclusion criteria (3 listed)
- planning to end employment at the agency within the next 3 months
- received a fourth-generation HIV test in the past 6 months
- HIV positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard referral for HIV testingParticipants receive standard referral for HIV testing in the community. | Behavioural | Treatment Group A, Treatment Group B |
| Online risk reduction trainingParticipants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them. | Behavioural | Treatment Group A, Treatment Group B |
| ReinforcementSystematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV | Behavioural | Treatment Group B |
Primary outcome
Initial HIV Testing by Clients
Time frame: From date of intervention until 6 month testing reminders.
HIV testing completion following initial intervention.
Repeat HIV Testing After 6 Month Reminders
Time frame: 6 month post-baseline through 12 month post-baseline
Whether the participant received an HIV test after receiving reminders for testing at 6 months post-initial intervention
Repeat HIV Testing After 12 Month Reminder
Time frame: 12 month post-baseline to 15 month post-baseline
Whether the participant received an HIV test following the 12 month reminder to get tested
Centers for Disease Control and Prevention Evaluation Toolkit About Routine HIV Screenings in Health Care Settings: Provider Questionnaire
Time frame: Baseline measure (pre-training) was completed prior to training in the intervention. Training occurred in a single day. Follow-up (post-training) was collected immediately following the one day training on the study intervention.
Assessment of providers' perspectives on barriers to HIV testing in their setting. Change in HIV testing attitudes among the clinician participants between pre- and post-training on the study intervention. Rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Items indicating more barriers to testing were reverse coded. Higher scores mean fewer perceived barriers to HIV testing. Scores are item means, so the range of possible scores is from 1 to 5.
The Perceived Attributes Scale - Relative Advantage Subscale
Time frame: Baseline measure (pre-training) was completed prior to training in the intervention. Training occurred in a single day. Follow-up (post-training) was collected immediately following the one day training on the study intervention.
Change in mean total scores on attitudes about reinforcement interventions (the Relative Advantage subscale). This subscale of the Perceived Advantage Scale measures a staff members' perception of how a new intervention (in this case, a reward intervention) would impact their work. Rated on a scale from 1 (strongly disagree) to 7 (strongly agree). There were 7 items on this subscale and total scores (from the subscale) are summed and then averaged. The lowest possible total score and mean = 7 and the highest possible total score and mean = 49. A higher score means a more positive perceived impact.
1 secondary outcome
Satisfaction With Training (Single Item)
Time frame: Assessed immediately following the single-day training on the study intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristyn Zajac, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard referral for HIV testing, Online risk reduction training and Reinforcement in people with HIV and HIV Testing, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial HIV Testing by Clients (time frame: From date of intervention until 6 month testing reminders.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.