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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04060420
Enrollment
2000
Registered
2019-08-19
Start date
2019-08-03
Completion date
2022-03-31
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Diseases

Brief summary

This trial evaluates the impact of providing comprehensive, community-based and peer-led sexual and reproductive health services to adolescents and young people aged 15 to 24 on their knowledge of their HIV status. The trial includes 20 clusters in two communities, half the clusters receive the intervention. After 18-months of implementation, a cross-sectional survey will be conducted to evaluate the impact of the intervention on the primary outcome: knowledge of HIV status.

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.

Interventions

OTHERComprehensive sexual and reproductive health services

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.

Sponsors

Zambart
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
Medical Research Council (funder; grant number: MR/R022216/1)
CollaboratorUNKNOWN
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

This study is a cluster-randomised trial, with a total of 20 clusters across two communities (10 clusters per community). Within each community, these 10 clusters have been randomised to intervention or control arm using restricted randomisation.

Eligibility

Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of HIV statusOutcome measured at single time point, but refers to previous 1 year period.Defined as self-reported HIV positive status or reporting an HIV-test within the previous 1 year period.

Secondary

MeasureTime frameDescription
ART useOutcome measured at single time point, but refers to the previous 1 year period.Self-reported current use of and retention on ART among individuals who are HIV positive
Coverage of sexual and reproductive health servicesOutcome measured at single time point, but refers to the previous 1 year period.The average number of services accessed at least once the previous 1 year period.
PrEP uptake and adherenceOutcome measured at single time point, but refers to the previous 1 year period.Self-reported uptake of and adherence to PrEP among individuals who are HIV negative
Met need for family planningOutcome measured at single time point, but refers to the previous 1 year period.Proportion of young women with met needs for family planning services
Pregnancies among young womenOutcome measured at single time point, but refers to the previous 1 year period.Proportion of young women reporting pregnancy
Uptake of medical male circumcision servicesOutcome measured at single time point, but refers to the previous 1 year period.Proportion of adolescent boys and young men accessing voluntary medical male circumcision services

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026