- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03938818
Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
Targeted Interventions to Address the Multi-level Effects of Gender-based Violence on PrEP Uptake and Adherence Among Adolescent Girls and Young Women in Siaya County, Kenya
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Intervention safety
- Feasibility of delivering the intervention within DREAMS operations
- Acceptability of the intervention to participants, staff, and male partners.
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:
- Self-report of new or ongoing GBV, social harms, serious adverse events, or unanticipated problems during study participation, in the intervention arm versus the comparison arm.
- Measures of feasibility including recruitment, retention, intervention participation, and fidelity of intervention delivery.
- Qualitative and quantitative reports of intervention acceptability among participants, quantitative reports of acceptability among providers, and qualitative reports of acceptability among male partners.
The endpoints for the secondary objectives are:
- PrEP uptake: Among participants who are not on PrEP at study enrollment, the proportion of who receive a PrEP prescription during follow-up in the intervention arm vs. the control arm
- PrEP adherence: 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 in the intervention arm vs. the control arm.
- PrEP persistence: Among study participants who were dispensed PrEP during the study, the proportion of scheduled PrEP refills that were dispensed, in the intervention arm compared to the control arm.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kisumu, Kenya
- Impact Research and Development Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) Age 15-24 years (inclusive);
- 2) HIV-negative, by self-report;
- 3) At high risk for acquiring HIV, as defined by the 2016 Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infections in Kenya;
- 4) Fluent in English, Dholuo, or Swahili;
- 5) Enrolled in DREAMS (defined by having a DREAMS identification (ID) number);
- 6) Lives within the Safe Space catchment area - 7) Willing and able to attend support groups over the 6-month period;
- 8) Potentially interested in PrEP and/or using PrEP already;
- 9) Able and willing to provide adequate locator information, as defined in site standard operating procedures (SOPs);
- 10)If aged 18 and above: Willing and able to provide informed consent;
- 11)If non-mature minor aged 15-17: Willing and able to provide assent and parent or guardian willing and able to provide parental consent;
- 12)If mature minor aged 15-17: Willing and able to provide informed consent or to provide assent and parent or guardian consent, per participant choice.
Exclusion Criteria:
- 1)Planning to relocate away from the study catchment area in the next 6 months;
- 2)Planning to travel away from the study catchment area for a time period that would interfere with study participation; or
- 3) Has any condition that, in the opinion of the site PI, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control
Standard of care will include PrEP delivery according to the usual DREAMS procedures
|
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.
|
EXPERIMENTAL: Tu'Washindi intervention
Standard of care will include PrEP delivery according to the usual DREAMS procedures. The Tu'Washindi intervention includes the following components:
|
The intervention includes the following components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention safety - survey tool
Time Frame: 3 months
|
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
Time Frame: 6 months
|
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
Time Frame: Throughout the study, approximately 6 months
|
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
Time Frame: Throughout the study, approximately 6 months
|
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
Time Frame: 6 months
|
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.
|
6 months
|
Acceptability of the behavioral intervention - quantitative data from participants
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-Exposure Prophylaxis (PrEP) uptake
Time Frame: 6 months
|
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
Time Frame: Throughout the study, approximately 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
Time Frame: 6 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Roberts, PhD, RTI International
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MSU/DRPI/MUERC/00418/17
- 1R34MH114519-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gender-Based Violence
-
RTI InternationalNo Means No WorldwideCompleted
-
University of CalgaryPublic Health Agency of Canada (PHAC)Recruiting
-
University of SheffieldUniversity of HuddersfieldCompleted
-
Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaRecruitingViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
-
Johns Hopkins UniversityCompleted
-
Emory UniversityCompletedIntimate Partner Violence | Gender Based ViolenceColombia
-
JhpiegoCompletedIntimate Partner Violence | Gender-based Violence | Reproductive CoercionNigeria
-
Universidad de GranadaOdense University Hospital; University of Southern DenmarkCompletedPregnancy Related | Intimate Partner Violence | Violence, Gender-BasedDenmark, Spain
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingViolence, Domestic | Violence | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Violence-Related SymptomUnited States
-
RTI InternationalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
Clinical Trials on Control
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryNot yet recruiting
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
National Taiwan University HospitalEnrolling by invitationCognitive Function | Atrial Fibrillation, PersistentTaiwan
-
Takeshi MorimotoUniversity of the RyukyusActive, not recruitingCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Vanderbilt University Medical CenterCompleted