IPVNCT05599581
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
A study testing Tu'Washindi in people with IPV and HIV, run by RTI International at 2 sites in Kenya.
Trial summary
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- What is being tested?
- Tu'Washindi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,562 participants
- Where
- 2 sitesKenya
- Study dates
- 29 Sep 2022to 22 Apr 2026
- 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
- To join the study potential AGYW participants must be:
- Age 15-24 years
- Female
- Currently in a sexual relationship with a male partner for at least 1 month
- Susceptible to HIV per modified Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) eligibility score
- (a) Taking PrEP or (b) interested in PrEP (i.e., thinks she would benefit from PrEP but is not currently taking it)
Show all 11Show fewer
- Resident of applicable ward
- Willing and able to attend support clubs for over 6 months
- Willing and able to provide adequate contact information for retention
- Fluent in one of the study languages (English, Dholuo, or Kiswahili)
- (a) If aged 18 and above: Willing and able to provide informed consent; or (b) if non-mature minor aged 15-17: willing and able to provide assent and parent or guardian willing and able to provide parental consent; or (c) 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
None listed.
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Impact Research and Development Organization (IRDO)
Kisumu
RTI International Africa Regional Office
Nairobi
About this study
Official title: Tu'Washindi Randomized Control Trial (RCT): A Relationship-focused Intervention to Reduce Intimate Partner Violence (IPV) and Increase Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Among Kenyan Adolescent Girls and Young Women (AGYW)
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact.
Through a cluster randomized controlled trial (cRCT) design, twenty-two administrative wards in Siaya County, western Kenya will be randomized in a 1:1 ratio to receive either the 6-month Tu'Washindi intervention plus usual HIV prevention services or usual HIV prevention services alone. Approximately 72 AGYW will be enrolled from each ward (N= 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation (not part of the clinical trial) will also be conducted using programmatic data, follow-up questionnaires from trial participants, approximately 500-1000 exit surveys with men, and approximately 100 qualitative interviews with AGYW participants, male partners, and intervention providers. These data will characterize fidelity and quality of intervention implementation, explore and test mechanisms of change, and capture contextual factors influencing intervention outcomes, with the goal of informing future refinement and implementation.
The population for this clinical trial study is AGYW ages 15-24 in Siaya County, Kenya.
Read the detailed description
The Tu'Washindi intervention was developed to address factors at the individual, partnership, and community levels that influence AGYW's response to IPV and their PrEP use. These factors are addressed in a three-component intervention delivered over 6 months: a PrEP adherence support club for AGYW, PrEP education events for couples offered in the context of a health fair ("Buddy Days"), and community sensitization about PrEP targeted toward AGYW's partners.
The pilot cluster randomized controlled trial of Tu'Washindi intervention demonstrated feasibility, high acceptability, implementation with fidelity, and promising effects on PrEP and IPV outcomes. Importantly, AGYW perceived Tu'Washindi as effective in achieving its objectives: Nearly all participants agreed that Tu'Washindi improved communication and reduced conflict with their partner, and more than half reported that it helped them gain partner support for their PrEP use. Providers believed the intervention resonated with community values, integrated well within the scope of their ongoing responsibilities, and was feasibly integrated into existing HIV prevention programming. PrEP uptake and adherence were both twice as high in the intervention arm as in the control arm (p<0.05), and less frequent or severe IPV among intervention arm participants were observed.
This study will consist of a cRCT design with the primary objectives of testing the effectiveness of the Tu'Washindi intervention on PrEP uptake and adherence immediately at intervention endline and 6 months post-delivery (Aim 1) and secondary objectives of testing the effectiveness of the intervention on IPV (Aim 2). The study setting will be Siaya County located in the former Nyanza Province in western Kenya. Siaya County has the second highest HIV incidence in Kenya (2.5% per year) and the highest prevalence of IPV in Kenya (22% of women aged 15-49 have reported sexual violence and 56% have reported physical violence at least once since age 15).
Twenty-two administrative wards in Siaya will be randomized in a 1:1 ratio and enroll approximately 72 AGYW from each (total N= 1,584) to receive either the Tu'Washindi intervention plus usual HIV prevention services, or usual HIV prevention services alone. After informed consent and baseline data collection, the Tu'Washindi intervention will be implemented in each intervention cluster while the control cluster continues with usual HIV prevention services. Participants will be followed for 12 months, with data collection visits at intervention midline (Study Month 3), intervention endline (Study Month 6), and at 6 months post-intervention (Study Month 12).
A prospective process evaluation will be conducted to characterize intervention implementation, explore theorized mechanisms of change, and capture contextual factors influencing study outcomes (Aim 3). Although the cRCT will answer primary research questions about intervention effectiveness, the process evaluation will elucidate why and how the intervention was able to achieve these outcomes or suggest reasons for lack of any observed change. Additionally, it will provide important insight into how the intervention might be refined, adapted, and implemented in the future.
- Being tested
- Tu'Washindi
- Keywords
- Adolescent Girls and Young Women (AGYW), Human Immunodeficiency Virus (HIV), Intimate Partner Violence (IPV), Kenya, Pre-exposure prophylaxis (PrEP)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tu'WashindiBehavioural
Tu'Washindi consists of 3 primary components:
- PrEP Adherence Support Clubs: Eight 2-hour sessions that occur over the intervention period: twice per month for the first 2 months \& once per month for the remaining 4 months. Sessions will use structured \& unstructured activities designed to improve outcomes expectations, increase self-efficacy to use PrEP safely \& consistently, increase peer support for PrEP use, provide access to community IPV resources \& provide skills for healthy communication \& PrEP disclosure with male partners.
- Community Male Sensitization conducted weekly over the first 3 months of the intervention period aimed to increase PrEP knowledge, reduce stigma, \& promote healthy relationship communication.
- Buddy Days, which take place 3 months into the intervention period, designed to bring participants \& their male partners together to learn about PrEP, discuss community attitudes \& concerns regarding PrEP use, \& promote HIV prevention \& family well-being.
| Study group | Role | What they receive |
|---|---|---|
| Tu'Washindi intervention plus usual HIV prevention services | Experimental | Participants in the intervention wards will receive the Tu'Washindi intervention plus access to evidence-based HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health, which is accessible to all AGYW. Receives: Behavioral: Tu'Washindi |
| Standard of care HIV (Usual) prevention services only | No intervention | Participants in the non-intervention (control) wards will have access to evidence-based standard of care HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health facilities, which is accessible to all AGYW. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective PrEP use (biomarker assessment)
Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.
Measured: 6-month follow-up
Effective PrEP use (biomarker assessment)
Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.
Measured: 12-month follow-up
Secondary outcomes (9)
IPV prevalence
Percent of participants reporting IPV since the last study visit, measured with the World Health Organization (WHO) VAWI and classified by the Tackling the Structural Drivers of HIV (STRIVE) Consortium definition: any act of severe physical or sexual violence, or >=2 acts of moderate physical violence.
Measured: 3-month follow-up
IPV prevalence
Percent of participants reporting IPV since the last study visit, measured with the World Health Organization (WHO) VAWI and classified by the Tackling the Structural Drivers of HIV (STRIVE) Consortium definition: any act of severe physical or sexual violence, or >=2 acts of moderate physical violence.
Measured: 6-month follow-up
IPV prevalence
Percent of participants reporting IPV since the last study visit, measured with the World Health Organization (WHO) VAWI and classified by the Tackling the Structural Drivers of HIV (STRIVE) Consortium definition: any act of severe physical or sexual violence, or >=2 acts of moderate physical violence.
Measured: 12-month follow-up
IPV severity
Percent of participants reporting any sexual or severe physical IPV since the last study visit, measured with WHO VAWI.
Measured: 3-month follow-up
IPV severity
Percent of participants reporting any sexual or severe physical IPV since the last study visit, measured with WHO VAWI.
Measured: 6-month follow-up
IPV severity
Percent of participants reporting any sexual or severe physical IPV since the last study visit, measured with WHO VAWI.
Measured: 12-month follow-up
IPV intensity
Self-report continuous score calculated from the number of specific violent acts reported and the reported frequency of each act (0=never; 1=once; 2=a few times; 3=often) since the last study visit, measured with WHO VAWI.
Measured: 3-month follow-up
IPV intensity
Self-report continuous score calculated from the number of specific violent acts reported and the reported frequency of each act (0=never; 1=once; 2=a few times; 3=often) since the last study visit, measured with WHO VAWI.
Measured: 6-month follow-up
IPV intensity
Self-report continuous score calculated from the number of specific violent acts reported and the reported frequency of each act (0=never; 1=once; 2=a few times; 3=often) since the last study visit, measured with WHO VAWI.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start29 Sep 2022
- Primary completion23 Mar 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IPVStudies 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
- Masking
- None (open label)
- Enrolment
- 1,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Impact Research & Development Organization, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Sarah Roberts, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599581
- Sponsor's protocol ID
- R01MH12567
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts ST, Minnis AM, Napierala S, Montgomery ET, Digolo L, Cottrell ML, Browne EN, Ndirangu J, Boke J, Agot K. Evaluation of the Tu'Washindi Na PrEP Intervention to Reduce Gender-Based Violence and Increase Preexposure Prophylaxis Uptake and Adherence Among Kenyan Adolescent Girls and Young Women: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 1;14:e55931. doi: 10.2196/55931.
PubMed 40168655
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tu'Washindi Randomized Control Trial (RCT): A Relationship-focused Intervention to Reduce Intimate Partner Violence (IPV) and Increase Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Among Kenyan Adolescent Girls and Young Women (AGYW)
- ClinicalTrials.gov ID
- NCT05599581
- Acronym / sponsor ID
- R01MH12567
- Keywords
- Adolescent Girls and Young Women (AGYW), Human Immunodeficiency Virus (HIV), Intimate Partner Violence (IPV), Kenya, Pre-exposure prophylaxis (PrEP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,562 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Impact Research & Development Organization, University of North Carolina, Chapel Hill
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 31 Oct 2022 (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 will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact.
Through a cluster randomized controlled trial (cRCT) design, twenty-two administrative wards in Siaya County, western Kenya will be randomized in a 1:1 ratio to receive either the 6-month Tu'Washindi intervention plus usual HIV prevention services or usual HIV prevention services alone. Approximately 72 AGYW will be enrolled from each ward (N= 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation (not part of the clinical trial) will also be conducted using programmatic data, follow-up questionnaires from trial participants, approximately 500-1000 exit surveys with men, and approximately 100 qualitative interviews with AGYW participants, male partners, and intervention providers. These data will characterize fidelity and quality of intervention implementation, explore and test mechanisms of change, and capture contextual factors influencing intervention outcomes, with the goal of informing future refinement and implementation.
The population for this clinical trial study is AGYW ages 15-24 in Siaya County, Kenya.
Detailed description
The Tu'Washindi intervention was developed to address factors at the individual, partnership, and community levels that influence AGYW's response to IPV and their PrEP use. These factors are addressed in a three-component intervention delivered over 6 months: a PrEP adherence support club for AGYW, PrEP education events for couples offered in the context of a health fair ("Buddy Days"), and community sensitization about PrEP targeted toward AGYW's partners.
The pilot cluster randomized controlled trial of Tu'Washindi intervention demonstrated feasibility, high acceptability, implementation with fidelity, and promising effects on PrEP and IPV outcomes. Importantly, AGYW perceived Tu'Washindi as effective in achieving its objectives: Nearly all participants agreed that Tu'Washindi improved communication and reduced conflict with their partner, and more than half reported that it helped them gain partner support for their PrEP use. Providers believed the intervention resonated with community values, integrated well within the scope of their ongoing responsibilities, and was feasibly integrated into existing HIV prevention programming. PrEP uptake and adherence were both twice as high in the intervention arm as in the control arm (p<0.05), and less frequent or severe IPV among intervention arm participants were observed.
This study will consist of a cRCT design with the primary objectives of testing the effectiveness of the Tu'Washindi intervention on PrEP uptake and adherence immediately at intervention endline and 6 months post-delivery (Aim 1) and secondary objectives of testing the effectiveness of the intervention on IPV (Aim 2). The study setting will be Siaya County located in the former Nyanza Province in western Kenya. Siaya County has the second highest HIV incidence in Kenya (2.5% per year) and the highest prevalence of IPV in Kenya (22% of women aged 15-49 have reported sexual violence and 56% have reported physical violence at least once since age 15).
Twenty-two administrative wards in Siaya will be randomized in a 1:1 ratio and enroll approximately 72 AGYW from each (total N= 1,584) to receive either the Tu'Washindi intervention plus usual HIV prevention services, or usual HIV prevention services alone. After informed consent and baseline data collection, the Tu'Washindi intervention will be implemented in each intervention cluster while the control cluster continues with usual HIV prevention services. Participants will be followed for 12 months, with data collection visits at intervention midline (Study Month 3), intervention endline (Study Month 6), and at 6 months post-intervention (Study Month 12).
A prospective process evaluation will be conducted to characterize intervention implementation, explore theorized mechanisms of change, and capture contextual factors influencing study outcomes (Aim 3). Although the cRCT will answer primary research questions about intervention effectiveness, the process evaluation will elucidate why and how the intervention was able to achieve these outcomes or suggest reasons for lack of any observed change. Additionally, it will provide important insight into how the intervention might be refined, adapted, and implemented in the future.
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
| Arm | Type | Receives |
|---|---|---|
| Tu'Washindi intervention plus usual HIV prevention services | Experimental | Behavioral: Tu'WashindiParticipants in the intervention wards will receive the Tu'Washindi intervention plus access to evidence-based HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health, which is accessible to all AGYW. |
| Standard of care HIV (Usual) prevention services only | No intervention | –Participants in the non-intervention (control) wards will have access to evidence-based standard of care HIV prevention services offered throughout the county. These include PrEP delivery through the Ministry of Health facilities, which is accessible to all AGYW. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age 15-24 years
- Female
- Currently in a sexual relationship with a male partner for at least 1 month
- Susceptible to HIV per modified Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) eligibility score
- (a) Taking PrEP or (b) interested in PrEP (i.e., thinks she would benefit from PrEP but is not currently taking it)
Key exclusion criteria (0 listed)
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'WashindiTu'Washindi consists of 3 primary components: 1. PrEP Adherence Support Clubs: Eight 2-hour sessions that occur over the intervention period: twice per month for the first 2 months \& once per month for the remaining 4 months. Sessions will use structured \& unstructured activities designed to improve outcomes expectations, increase self-efficacy to use PrEP safely \& consistently, increase peer support for PrEP use, provide access to community IPV resources \& provide skills for healthy communication \& PrEP disclosure with male partners. 2. Community Male Sensitization conducted weekly over the first 3 months of the intervention period aimed to increase PrEP knowledge, reduce stigma, \& promote healthy relationship communication. 3. Buddy Days, which take place 3 months into the intervention period, designed to bring participants \& their male partners together to learn about PrEP, discuss community attitudes \& concerns regarding PrEP use, \& promote HIV prevention \& family well-being. | Behavioural | Tu'Washindi intervention plus usual HIV prevention services |
Primary outcome
Effective PrEP use (biomarker assessment)
Time frame: 6-month follow-up
Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.
Effective PrEP use (biomarker assessment)
Time frame: 12-month follow-up
Percent of all study participants with biomarker tenofovir-diphosphate levels indicating consistent PrEP use (≥4 doses per week) for the past 2 months measured as concentrations in dried blood spots. Represents a composite outcome of PrEP initiation, persistence, and high execution to capture these steps in the HIV prevention continuum.
9 secondary outcomes
IPV prevalence
Time frame: 3-month follow-up
IPV prevalence
Time frame: 6-month follow-up
IPV prevalence
Time frame: 12-month follow-up
IPV severity
Time frame: 3-month follow-up
IPV severity
Time frame: 6-month follow-up
IPV severity
Time frame: 12-month follow-up
IPV intensity
Time frame: 3-month follow-up
IPV intensity
Time frame: 6-month follow-up
IPV intensity
Time frame: 12-month follow-up
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 7 Aug 2026.
- Derived from this study: PubMed 40168655Roberts ST, Minnis AM, Napierala S, Montgomery ET, Digolo L, Cottrell ML, Browne EN, Ndirangu J, Boke J, Agot K. Evaluation of the Tu'Washindi Na PrEP Intervention to Reduce Gender-Based Violence and Increase Preexposure Prophylaxis Uptake and Adherence Among Kenyan Adolescent Girls and Young Women: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 1;14:e55931. doi: 10.2196/55931.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tu'Washindi in people with IPV and HIV, run by RTI International at 2 sites 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 0 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effective PrEP use (biomarker assessment) (time frame: 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05599581, which also lists 1 linked publication.
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 7 Aug 2026.