- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060420
Yathu Yathu: An Impact Evaluation of Community-based Peer-led Sexual and Reproductive Health Services
Yathu Yathu ("For us, by us"): A Cluster-randomized Trial of Comprehensive Community-based Peer-led Sexual and Reproductive Health Services for Adolescents and Young People Aged 15 to 24 in Lusaka, Zambia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Through a cluster-randomised trial, this study will address the research question: Do community-based peer-led interventions increase knowledge of HIV status and coverage of sexual and reproductive health services among adolescents and young people in Lusaka, Zambia, compared to current standard of care? To address this question, the study aims to build a rigorous evidence-base of the effectiveness of community-based, peer-led HIV services designed with and for adolescents and young people living in Lusaka, Zambia, and evidence of the process of delivering such an intervention to support replication and scale-up if the intervention is effective.
The intervention, called Yathu Yathu (For us, by us), was designed with adolescents and young people in a formative research study. The Yathu Yathu intervention includes: 1) delivery of comprehensive sexual and reproductive health services by peer support workers, lay counsellors and a nurse at community-based hubs, and 2) an innovative "prevention points card" system. The prevention points cards are intended to incentivise service use by allowing adolescents and young people to accrue points for accessing services and redeem rewards using these points. At the start of the intervention period, trained enumerators will systematically visit and enumerate all households in the 20 study clusters. For household members aged 15 to 24, the enumerators will offer the individual a prevention points card. A third component is mobile phone-based support groups. These groups will initially be set-up among HIV-positive pregnant women, as a means to offer psychosocial support, with expansion of this portion of the intervention to other groups planned.
To evaluate the impact of the Yathu Yathu intervention, a cross-sectional survey among a random sample of approximately 2000 adolescents and young people will be conducted 18-months after implementation of the intervention. An embedded mixed-method process evaluation will provide evidence of service acceptability, feasibility, and of adolescents and young people's experiences with services. An economic evaluation will provide evidence of the costs and cost-effectiveness of the intervention package. Through these methods, this study will provide a rigorous and comprehensive evidence-base of whether Yathu Yathu can increase adolescents and young people access to sexual and reproductive health services, thereby contributing to their health and well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lusaka, Zambia
- Zambart
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for the cross-sectional survey to be conducted 18 months after implementation of the Yathu Yathu intervention:
- 16 - 26 years of age at time of the survey (15 to 24 at the time of household enumeration and distribution of the Yathu Yathu prevention points card)
- Residing within the cluster during enumeration of the cluster
- Received a prevention points card at the time of household enumeration
- Able and willing to provide informed consent.
Exclusion Criteria:
- Anything that, in the opinion of the investigator, would preclude informed 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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive sexual and reproductive health services
In clusters randomised to the Yathu Yathu intervention, the comprehensive, community-based and peer-led intervention is being delivered.
In addition to delivery of sexual and reproductive health services through community-based hubs, the intervention includes the Yathu Yathu prevention points cards, with which adolescents and young people can accrue points for accessing services at the Yathu Yathu hub and local health facility, and redeem rewards using these points.
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The intervention includes community-based and peer-led delivery of comprehensive sexual and reproductive health services and a Yathu Yathu prevention points card, which is a card that adolescents and young people can use to gain points for accessing services and use these points to redeem rewards.
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No Intervention: Standard of care
In the comparison arm, adolescents and young people will have access to sexual and reproductive health services at the local health facility.
They will also have a Yathu Yathu prevention points card, with which they can accrue points for accessing sexual and reproductive health services at the local health facility and redeem rewards using these points.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of HIV status
Time Frame: Outcome measured at single time point, but refers to previous 1 year period.
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Defined as self-reported HIV positive status or reporting an HIV-test within the previous 1 year period.
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Outcome measured at single time point, but refers to previous 1 year period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coverage of sexual and reproductive health services
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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The average number of services accessed at least once the previous 1 year period.
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Outcome measured at single time point, but refers to the previous 1 year period.
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Uptake of medical male circumcision services
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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Proportion of adolescent boys and young men accessing voluntary medical male circumcision services
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Outcome measured at single time point, but refers to the previous 1 year period.
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Met need for family planning
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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Proportion of young women with met needs for family planning services
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Outcome measured at single time point, but refers to the previous 1 year period.
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PrEP uptake and adherence
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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Self-reported uptake of and adherence to PrEP among individuals who are HIV negative
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Outcome measured at single time point, but refers to the previous 1 year period.
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ART use
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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Self-reported current use of and retention on ART among individuals who are HIV positive
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Outcome measured at single time point, but refers to the previous 1 year period.
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Pregnancies among young women
Time Frame: Outcome measured at single time point, but refers to the previous 1 year period.
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Proportion of young women reporting pregnancy
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Outcome measured at single time point, but refers to the previous 1 year period.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helen Ayles, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- Phiri MM, Hensen B, Schaap A, Sigande L, Simuyaba M, Simwinga M, Floyd S, Fidler S, Hayes R, Ayles H. Adapting community-based sexual and reproductive health services for adolescents and young people aged 15-24 years in response to COVID-19 in Lusaka, Zambia: the implications on the uptake of HIV testing services. BMC Health Serv Res. 2022 Apr 14;22(1):503. doi: 10.1186/s12913-022-07878-7.
- Simuyaba M, Hensen B, Phiri M, Mwansa C, Mwenge L, Kabumbu M, Belemu S, Shanaube K, Schaap A, Floyd S, Fidler S, Hayes R, Ayles H, Simwinga M. Engaging young people in the design of a sexual reproductive health intervention: Lessons learnt from the Yathu Yathu ("For us, by us") formative study in Zambia. BMC Health Serv Res. 2021 Jul 29;21(1):753. doi: 10.1186/s12913-021-06696-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17104
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.
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