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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH134680 | U.S. NIH Grant/Contract | View source | |
| IRB-300013932 | Other Identifier | UAB |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.
Women in Uganda who are planning for pregnancy, pregnant, or postpartum and have a partner living with HIV are vulnerable to acquiring HIV.
Adapting this intervention to community clinics and testing effectiveness aligns with global and Ugandan Ministry of Health goals to reduce HIV incidence among women of reproductive age and eliminate perinatal transmission. Additionally, costing analyses will be conducted to determine the cost of implementing HF-PrEP from both payer and societal perspectives. This work will inform future intervention implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Families PrEP Counselling Intervention | Active Comparator | Intervention Health Care Centers will offer the guideline-based PrEP standard of care plus trained staff will conduct the 3-session Healthy Families-PrEP intervention with HIV-uninfected women with plans for pregnancy in the next year and concerns about or exposure to HIV. |
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| Standard of care PrEP services for perinatal women | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Families PrEP Counselling Intervention | Drug | Healthy Families-PrEP intervention with HIV-uninfected women with plans for pregnancy in the next year and concerns about or exposure to HIV. Session 1 focuses on providing information about HIV prevention in the context of reproductive goals (using tools with locally developed images), increasing motivation for behavior change, and developing a safer conception plan (e.g., PrEP uptake, PrEP adherence, couples-based counselling and testing, delaying condomless sex until partner serostatus known and, if living with HIV, virally suppressed). Sessions 2 and 3 (conducted at 1 and 3 months) review the safer conception plan and revise as needed (e.g., changes in readiness to initiate PrEP, partner serostatus knowledge) and engaging in problem-solving barriers (including structural) to plan execution, communication skills training, and motivational strategies for successful plan execution. Participants receive quarterly adherence counseling using tools developed by this team. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP initiation - Women who start to use PrEP | The primary effectiveness outcome will be proportion of women at 6 months with intracellular TFV-DP concentration consistent with taking at least 4 doses per week. | Enrolment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Women who continue to use PrEP when they become pregnant | Investigators will explore secondary outcomes of PrEP adherence patterns over perinatal periods with quarterly blood draws for TFV measurements | Enrolment to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Women with pregnancy intentions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lynn T Matthews, MD, MPH | Contact | 617-650-5257 | lynn.matthews@yale.edu | |
| Patricia M Smith, MSc | Contact | 9024395214 | pmsmith@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lynn T Matthews, MD, MPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University of Science and Technology | Mbarara | Uganda |
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