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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH134681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Kenya Medical Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| Partners in Health and Research Development |
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Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, we will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya. Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. We will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care. Our primary aim will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care PrEP Program | No Intervention | In the control phase, clinics will offer standard of care PrEP program, which includes daily oral PrEP, for young women. | |
| Multiple Product PrEP Program | Active Comparator | In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Product PrEP Program | Drug | In the intervention phase, clinics will offer a multi-product PrEP program, which includes daily oral PrEP and other forms of PrEP that are available. To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available. Others will be added as they become available in Kenya. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP initiation | Women who start to use PrEP | From enrolment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP persistence at 3 months | Women who continue to use PrEP 3 months since they initiated PrEP | From enrolment to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP persistence at 6 months | Women who continue to use PrEP 6 months since they initiated PrEP | Enrolment to 6 months |
Inclusion Criteria for Adolescent Girls and Young Women seeking reproductive health services:
Age ≥18 years and ≤30years. Seeking a reproductive health service from one of the project facilities (reproductive health services include but are not limited to family planning, maternal and child health, postnatal care).
AGYW receiving reproductive health-related services through OPD, or other departments are eligible. AGYW receiving reproductive health-related services through other departments are eligible.
Willing and able to partake in an informed consent process. Able to speak and read in Kiswahili or English.
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renee Heffron, PhD, MPH | Contact | 205-934-7349 | rheffron@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nelly Mugo, MBChB, MMed, MPH | Kenya Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute and Partners in Health & Research Development | Recruiting | Thika | Kiambu County | Kenya |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| UNKNOWN |
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|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| 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 |