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Yathu Yathu: An Impact Evaluation of Community-based Peer-led Sexual and Reproductive Health Services

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Active
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Comprehensive sexual and reproductive health services
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zambart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Comprehensive sexual and reproductive health services

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knowledge of HIV status
Defined as self-reported HIV positive status or reporting an HIV-test within the previous 1 year period.

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2019
Last Updated
November 23, 2021
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Zambart, Imperial College London, Medical Research Council (funder; grant number: MR/R022216/1)
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1. Study Identification

Unique Protocol Identification Number
NCT04060420
Brief Title
Yathu Yathu: An Impact Evaluation of Community-based Peer-led Sexual and Reproductive Health Services
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2019 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Zambart, Imperial College London, Medical Research Council (funder; grant number: MR/R022216/1)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive sexual and reproductive health services
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive sexual and reproductive health services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of HIV status
Description
Defined as self-reported HIV positive status or reporting an HIV-test within the previous 1 year period.
Time Frame
Outcome measured at single time point, but refers to previous 1 year period.
Secondary Outcome Measure Information:
Title
Coverage of sexual and reproductive health services
Description
The average number of services accessed at least once the previous 1 year period.
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.
Title
Uptake of medical male circumcision services
Description
Proportion of adolescent boys and young men accessing voluntary medical male circumcision services
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.
Title
Met need for family planning
Description
Proportion of young women with met needs for family planning services
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.
Title
PrEP uptake and adherence
Description
Self-reported uptake of and adherence to PrEP among individuals who are HIV negative
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.
Title
ART use
Description
Self-reported current use of and retention on ART among individuals who are HIV positive
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.
Title
Pregnancies among young women
Description
Proportion of young women reporting pregnancy
Time Frame
Outcome measured at single time point, but refers to the previous 1 year period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Ayles
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zambart
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35421966
Citation
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.
Results Reference
derived
PubMed Identifier
34325696
Citation
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.
Results Reference
derived

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Yathu Yathu: An Impact Evaluation of Community-based Peer-led Sexual and Reproductive Health Services

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