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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH137775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South.
Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator | This arm will receive the intervention first. |
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| Waitlist Control | Active Comparator | This arm will receve the intervention after the wait period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMPOWER | Behavioral | EMPOWER, a group-based 6 sessions telehealth behavioral intervention, will comprise sexual health goals and values elicitation, sexual health plan development, and motivational enhancement skills will be used to promote effective HIV prevention decision-making within the relationship context, incorporating the sexual values of each participant. This will allow each participant to develop a personalized, tailored sexual health plan that includes PrEP deliberation to enhance PrEP decision-making, uptake and persistence within a culturally congruent and empowering program that aims to reduce stigma around HIV and barriers to access. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of EMPOWER Intervention | Enrollment rate will be used an indicator of the feasibility of the intervention | From enrollment to the end of data collection and analysis at 6 months |
| Acceptability of EMPOWER Intervention | Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores | From enrollment to the end of data collection and analysis at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Rifat Haider, Ph.D. | Contact | 803-477-4289 | haider@uga.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empowerment Resource Center | Atlanta | Georgia | 30303 | United States |
Investigators will not share the IPD of the participants of this study with others because the investigaotrs will only report the aggregated results of the study.
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Investigators will recruit 80 Black women from HIV testing sites who have engaged in HIV risk behavior in the prior three months and randomly assign them to either the EMPOWER intervention condition (n=40) or a standard of care control condition (n=40). Standard of care includes provision of opt-out PrEP. Both conditions will receive EMPOWER. However, the standard of care control condition will receive the intervention after the 3-month follow-up assessment. The active intervention period will last 9 weeks (5 weekly sessions and a booster session after 4 weeks).
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