- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03768986
Un intervento di rinforzo per aumentare il test HIV tra le donne a rischio
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06030
- UConn Health
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Treatment Group A
Standard referral for HIV testing and online HIV risk reduction training |
Participants receive standard referral for HIV testing in the community. Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them. |
|
Sperimentale: Treatment Group B
Standard referral for HIV testing and online HIV risk reduction training plus reinforcement |
Participants receive standard referral for HIV testing in the community. Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them. Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Initial HIV Testing by Clients
Lasso di tempo: From date of intervention until 6 month testing reminders.
|
HIV testing completion following initial intervention. |
From date of intervention until 6 month testing reminders.
|
|
Repeat HIV Testing After 6 Month Reminders
Lasso di tempo: 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 |
6 month post-baseline through 12 month post-baseline
|
|
Repeat HIV Testing After 12 Month Reminder
Lasso di tempo: 12 month post-baseline to 15 month post-baseline
|
Whether the participant received an HIV test following the 12 month reminder to get tested |
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
Lasso di tempo: 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. |
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
Lasso di tempo: 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. |
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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Satisfaction With Training (Single Item)
Lasso di tempo: Assessed immediately following the single-day training on the study intervention
|
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. |
Assessed immediately following the single-day training on the study intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kristyn Zajac, Ph.D., UConn Health
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19-018-1
- R01MD013550 (Sovvenzione/contratto NIH degli Stati Uniti)
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