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| ID | Type | Description | Link |
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| 1R34MH114519-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Impact Research & Development Organization | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya. It will test a pilot intervention that will address barriers to pre-exposure prophylaxis (PrEP) uptake and adherence in adolescent girls and young women (AGYW) to reduce their risk to HIV acquisition, with a focus on barriers stemming from male partners and gender-based violence.
This study is designed to assess feasibility, safety, and preliminary effects of a behavioral intervention aimed at increasing pre-exposure prophylaxis (PrEP) uptake and adherence in adolescent girls and young women (AGYW), with a focus on barriers stemming from male partners and gender-based violence, through a pilot cluster randomized-controlled trial (RCT). This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya. Six DREAMS Safe Spaces and their catchment areas will be randomized to receive this community-level intervention or standard of care. Primary outcomes will include feasibility (recruitment, retention) and safety (ongoing or renewed experience of GBV). The investigators will also determine whether the intervention shows promise in increasing PrEP uptake, adherence, and persistence at 6 months. After the intervention, small group discussions, in-depth interviews with male partners, and provider questionnaires will explore acceptability and effects on PrEP decision making and use.
Population: AGYW ages 15-24 enrolled in the DREAMS Initiative in Siaya County, Kenya, and, for in-depth interviews only, a subset of male partners of DREAMS participants.
Objectives: The goal of this work is to test the feasibility, acceptability, safety, and preliminary effects of the intervention on PrEP uptake and adherence among AGYW.
The primary objectives are to assess:
The secondary objectives are to measure the intervention's effect on PrEP uptake, adherence, and persistence at 6 months.
Endpoints: The endpoints for the primary objectives are:
The endpoints for the secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Standard of care will include PrEP delivery according to the usual DREAMS procedures |
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| Tu'Washindi intervention | Experimental | Standard of care will include PrEP delivery according to the usual DREAMS procedures. The Tu'Washindi intervention includes the following components:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tu'Washindi intervention | Behavioral | The intervention includes the following components:
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| Measure | Description | Time Frame |
|---|---|---|
| Intervention safety - survey tool | Self-report of experience of social harms in the past 3 months and violence or controlling behavior using an adapted version of the World Health Organization's questions on violence against women. Behaviors are reported for every experience in the past 3 months and frequency of experience (e.g., once, few times, many times). | 3 months |
| Intervention safety - survey tool | Self-report of experience of social harms in the past 3 months and violence or controlling behavior using an adapted version of the World Health Organization's questions on violence against women. Behaviors are reported for every experience in the past 3 months and frequency of experience (e.g., once, few times, many times). | 6 months |
| Intervention safety - form | Reports of new or ongoing gender-based violence (GBV), social harms, serious adverse events, or unanticipated problems during study participation. Information will be self-reported using an specially-developed form | Throughout the study, approximately 6 months |
| Feasibility of the behavioral intervention - Process Indicators | Measures of feasibility including recruitment timelines and numbers enrolled, retention rates, intervention participation measured by attendance at support club sessions and other intervention activities, and fidelity of intervention delivery measured through documented observations of intervention delivery capturing activities administered and ratings of quality. | Throughout the study, approximately 6 months |
| Acceptability of the behavioral intervention - qualitative data from participants | Acceptability measures include qualitative reports of intervention acceptability among participants. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the participant's life. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Exposure Prophylaxis (PrEP) uptake | Among participants who are not on PrEP at study enrollment, the number who receive a PrEP prescription during follow-up. This will be measured through retrospective clinic record extraction. | 6 months |
| Proportion of participants with Pre-Exposure Prophylaxis (PrEP) adherence > 85% at six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Roberts, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Impact Research and Development Organization | Kisumu | Kenya |
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cluster randomized-controlled trial (RCT)
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| Control | Other | Standard of care will include PrEP delivery according to the usual DREAMS procedures, including attendance at routine Safe Space meetings and routine PrEP provision at the Safe Space, if applicable. |
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| 6 months |
| Acceptability of the behavioral intervention - quantitative data from participants | Quantitative reports of intervention acceptability among participants. Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options. | 6 months |
| Acceptability of the behavioral intervention - quantitative data from providers | Satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options. | 6 months |
| Acceptability of the behavioral intervention - qualitative data from male partners | Qualitative reports of intervention acceptability among male partners. These will include in-depth interviews covering topics such as satisfaction with content, delivery, and length of the intervention, as well as reported impact on the male partner's life. | 6 months |
Among participants who were dispensed PrEP during the study, the proportion with >85% adherence over the duration of PrEP use and in the last month of PrEP use, according to Wisepill data. This information will be collected using the Wisepill electronic data monitoring (EDM) device that collects information on pill adherence in real-time. |
| Throughout the study, approximately 6 months |
| Pre-Exposure Prophylaxis (PrEP) persistence among participants at six months | Among study participants who were dispensed PrEP during the study, the number of scheduled PrEP refills that were dispensed. This will be measured through retrospective clinic record abstraction reflecting clinic visits throughout the study period. | 6 months |