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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH108412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Witwatersrand, South Africa | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.
In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.
Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-uninfected women | Other | A sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP for Safer Conception | Behavioral | Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of uptake of and adherence to PrEP | The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up. | minimum of 12 months through pregnancy outcome (maximum 21 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Safer Conception Strategies | Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence. | minimum of 12 months through pregnancy outcome (maximum 21 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn T Matthews, MD, MPH | Mass General Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal, Adolescent, and Child Health Research Unit (MRU) | Durban | KwaZulu-Natal | 4001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921636 | Derived | Kwach B, Odoyo JB, Lauff AR, Omollo V, Rono B, Ogello V, Mann V, Kwena Z, Thomas K, Sharma M, Morton JF, Ngure K, Bukusi E, Mugwanya KK, PrEP Care Team OS. Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya. BMJ Open. 2025 Sep 8;15(9):e097792. doi: 10.1136/bmjopen-2024-097792. | |
| 38752557 | Derived | Matthews LT, Jaggernath M, Kriel Y, Smith PM, Haberer JE, Baeten JM, Hendrix CW, Ware NC, Moodley P, Pillay M, Bennett K, Bassler J, Psaros C, Hurwitz KE, Bangsberg DR, Smit JA. Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa. AIDS. 2024 Jul 15;38(9):1342-1354. doi: 10.1097/QAD.0000000000003925. Epub 2024 May 27. |
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All participants are assigned to the Safer Conception study intervention.
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| 31350241 | Derived | Matthews LT, Jaggernath M, Kriel Y, Smith PM, O'Neil K, Haberer JE, Hendrix C, Baeten JM, Ware NC, Wirth K, Psaros C, Bangsberg DR, Smit JA. Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa. BMJ Open. 2019 Jul 26;9(7):e027227. doi: 10.1136/bmjopen-2018-027227. |