Gender-Based ViolenceNCT03938818
Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
A study testing Tu'Washindi intervention in people with Gender-Based Violence, run by RTI International at 1 site in Kenya.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender-Based Violence
- What is being tested?
- Tu'Washindi intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteKenya
- Study dates
- 15 Apr 2019to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Gender-Based Violence
- Being tested
- Tu'Washindi intervention, Control
- Keywords
- Gender-Based Violence, PrEP (Pre-exposure Prophylaxis), AIDS Prevention, HIV Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tu'Washindi interventionBehavioural
The intervention includes the following components:
- PrEP sensitization for men (community level). These activities will aim to provide men with basic information about PrEP and will be used to prepare men for more effective engagement in Buddy Days, described below.
- "Buddy Days" (partner level). Buddy days will target male partner engagement by inviting couples to attend a community-wide event with health screenings, and PrEP sensitization, which aim to facilitate further communications about PrEP and increase men's support for AGYW's PrEP use.
- Adherence support clubs (individual and peer levels). Support clubs will provide a forum for AGYW to discuss challenges and successes around PrEP use in relationships, including in the context of partner violence. Participation in these groups is hypothesized to increase self-efficacy for PrEP use by reducing social isolation and providing additional positive role-modeling from peer leaders.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard of care will include PrEP delivery according to the usual DREAMS procedures Receives: Other: Control |
| 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:
1. PrEP sensitization for men (community level).
2. "Buddy Days" (partner level).
3. Adherence support clubs (individual and peer levels). Receives: Behavioral: Tu'Washindi intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Proportion of participants with Pre-Exposure Prophylaxis (PrEP) adherence > 85% at six 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start15 Apr 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-Based ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized-controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Impact Research & Development Organization, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Roberts, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938818
- Sponsor's protocol ID
- MSU/DRPI/MUERC/00418/17
- Other IDs
- 1R34MH114519-01
- Status last verified
- Jan 2020
- First submitted
- 17 Apr 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03938818
- Acronym / sponsor ID
- MSU/DRPI/MUERC/00418/17
- Conditions
- Gender-Based Violence
- Keywords
- Gender-Based Violence, PrEP (Pre-exposure Prophylaxis), AIDS Prevention, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Impact Research & Development Organization, National Institute of Mental Health (NIMH)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized-controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlStandard of care will include PrEP delivery according to the usual DREAMS procedures |
| Tu'Washindi intervention | Experimental | Behavioral: Tu'Washindi interventionStandard of care will include PrEP delivery according to the usual DREAMS procedures. The Tu'Washindi intervention includes the following components: 1. PrEP sensitization for men (community level). 2. "Buddy Days" (partner level). 3. Adherence support clubs (individual and peer levels). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tu'Washindi interventionThe intervention includes the following components: 1. PrEP sensitization for men (community level). These activities will aim to provide men with basic information about PrEP and will be used to prepare men for more effective engagement in Buddy Days, described below. 2. "Buddy Days" (partner level). Buddy days will target male partner engagement by inviting couples to attend a community-wide event with health screenings, and PrEP sensitization, which aim to facilitate further communications about PrEP and increase men's support for AGYW's PrEP use. 3. Adherence support clubs (individual and peer levels). Support clubs will provide a forum for AGYW to discuss challenges and successes around PrEP use in relationships, including in the context of partner violence. Participation in these groups is hypothesized to increase self-efficacy for PrEP use by reducing social isolation and providing additional positive role-modeling from peer leaders. | Behavioural | Tu'Washindi intervention |
| ControlStandard 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. | Other | Control |
Primary outcome
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).
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).
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
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.
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.
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.
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.
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.
3 secondary outcomes
Pre-Exposure Prophylaxis (PrEP) uptake
Time frame: 6 months
Proportion of participants with Pre-Exposure Prophylaxis (PrEP) adherence > 85% at six months
Time frame: Throughout the study, approximately 6 months
Pre-Exposure Prophylaxis (PrEP) persistence among participants at six months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Roberts, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tu'Washindi intervention in people with Gender-Based Violence, run by RTI International at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention safety - survey tool (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.