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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH114544 | U.S. NIH Grant/Contract | View source | |
| AID-OAA-A-15-00034 | Other Grant/Funding Number | US Agency for International Development |
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| Name | Class |
|---|---|
| Desmond Tutu HIV Foundation | OTHER |
| Wits Reproductive Health and HIV Institute | OTHER |
| Kenya Medical Research Institute | OTHER |
| United States Agency for International Development (USAID) |
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The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
PrEP will be delivered to young women according to emerging national guidelines in family planning clinics (Kisumu, Kenya), youth friendly clinics (Johannesburg, South Africa), and mobile youth friendly clinics (Cape Town, South Africa). The investigators will evaluate PrEP delivery and follow cohorts of young women at each clinic location to understand PrEP uptake and use. In the Kisumu clinics, the investigators will also offer expedited partner therapy and partner HIV self-tests to women who test positive for chlamydia and/or gonorrhea. At one clinic in Johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate PrEP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young women | Sexually active HIV-uninfected women between 16-25 years of age will be given Truvada. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truvada | Drug | A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate PrEP delivery models for young women in different settings and geographies. | Mixed methods assessment of how PrEP is implemented at the user, provider, health care facility, and community levels. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP initiation | Measure the number of young women who initiate PrEP. | Up to 36 months |
| PrEP adherence | Adherence by young women to PrEP. Adherence will be measured by the timing of PrEP refills and self-reported PrEP use. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV and a subset who remain HIV uninfected. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess cost and cost-effectiveness of PrEP when delivered in public health clinics. | Time-motion studies will be conducted to define the cost and cost effectiveness of the intervention in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness of PrEP over routine HIV care. | Up to 36 months |
Inclusion Criteria:
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Sexually active HIV uninfected women ages 16-25 will be recruited from family planning clinics, youth clinics, and youth outreach programs.
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| Name | Affiliation | Role |
|---|---|---|
| Connie L Celum, MD, MPH | University of Washington | Principal Investigator |
| Jared M Baeten, MD, PhD | University of Washington | Principal Investigator |
| Rachel Johnson, MPH | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute | Kisumu | Kenya | ||||
| Desmond Tutu HIV Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36170124 | Derived | Katz AWK, Roberts S, Rousseau E, Khoza MN, Mogaka F, Bukusi E, Delany-Moretlwe S, Bekker LG, Morton JF, Johnson R, Baeten JM, Celum C, van der Straten A. Qualitative Analysis Using Social Maps to Explore Young Women's Experiences With Social Support of their Oral PrEP Use in Kenya and South Africa. J Assoc Nurses AIDS Care. 2023 Jan-Feb 01;34(1):45-57. doi: 10.1097/JNC.0000000000000363. Epub 2022 Sep 23. | |
| 35822945 | Derived | Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962. |
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Data from the POWER Cohort Study will be available at the end of the project by contacting the Principal Investigators.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| FED |
| RTI International | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| University of Pittsburgh | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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Dried blood spots
| Up to 36 months |
| HIV seroconversion | Assess HIV incidence during PrEP use and non-use. | Up to 36 months |
| Evaluate the acceptability of delivering expedited partner therapy. |
Measure the number of women who accept STI expedited partner therapy and HIV self-test kits for their partners. |
| Up to 36 months |
| Assess the effect of a decision support tool on PrEP uptake | Using a randomized design, evaluate if a decision support tool increases PrEP uptake. | Up to 36 months |
| Evaluate the impact of HIV self-testing on PrEP delivery among young women receiving PrEP | Using a pretest posttest design, evaluate the feasibility of integrating HIV self-testing into PrEP delivery. | Up to 12 months |
| Cape Town |
| South Africa |
| Wits Reproductive Health and HIV Institute | Johannesburg | South Africa |
| 35354456 | Derived | Roche SD, Barnabee G, Omollo V, Mogaka F, Odoyo J, Bukusi EA, Morton JF, Johnson R, Celum C, Baeten JM, O'Malley G. Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study. BMC Health Serv Res. 2022 Mar 30;22(1):422. doi: 10.1186/s12913-022-07742-8. |
| 33859147 | Derived | Omollo V, Bukusi EA, Kidoguchi L, Mogaka F, Odoyo JB, Celum C, Morton J, Johnson R, Baeten JM. A Pilot Evaluation of Expedited Partner Treatment and Partner Human Immunodeficiency Virus Self-Testing Among Adolescent Girls and Young Women Diagnosed With Chlamydia trachomatis and Neisseria gonorrhoeae in Kisumu, Kenya. Sex Transm Dis. 2021 Oct 1;48(10):766-772. doi: 10.1097/OLQ.0000000000001430. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |