NCT04060420

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

August 12, 2019

Last Update Submit

November 23, 2021

Conditions

HIV InfectionsSexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

  • Knowledge of HIV status

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

    Outcome measured at single time point, but refers to previous 1 year period.

Secondary Outcomes (6)

  • Coverage of sexual and reproductive health services

    Outcome measured at single time point, but refers to the previous 1 year period.

  • Uptake of medical male circumcision services

    Outcome measured at single time point, but refers to the previous 1 year period.

  • Met need for family planning

    Outcome measured at single time point, but refers to the previous 1 year period.

  • PrEP uptake and adherence

    Outcome measured at single time point, but refers to the previous 1 year period.

  • ART use

    Outcome measured at single time point, but refers to the previous 1 year period.

  • +1 more secondary outcomes

Study Arms (2)

Comprehensive sexual and reproductive health services

EXPERIMENTAL

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.

Other: Comprehensive sexual and reproductive health services

Standard of care

NO INTERVENTION

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.

Interventions

Comprehensive sexual and reproductive health servicesOTHER

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.

Comprehensive sexual and reproductive health services

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zambart

Lusaka, Zambia

Location

Related Publications (6)

  • Rotsaert A, Phiri M, Sigande L, Schaap A, Zulu-Phiri R, Simuyaba M, Mwape L, Floyd S, Fidler S, Hayes R, Simwinga M, Ayles H, Hensen B. Unmet need for contraceptives and unintended pregnancies among adolescent girls and young women aged 15 to 24 in Zambia: insights from the Yathu Yathu trial. Reprod Health. 2025 Nov 12;22(1):229. doi: 10.1186/s12978-025-02202-y.

    PMID: 41225474DERIVED

  • Phiri MM, Schaap A, Hensen B, Sigande L, Simuyaba M, Mwenge L, Zulu-Phiri R, Mwape L, Floyd S, Fidler S, Hayes R, Simwinga M, Ayles H. The impact of an innovative community-based peer-led intervention on uptake and coverage of sexual and reproductive health services among adolescents and young people 15-24 years old: results from the Yathu Yathu cluster randomised trial. BMC Public Health. 2024 May 28;24(1):1424. doi: 10.1186/s12889-024-18894-z.

    PMID: 38807091DERIVED

  • Hensen B, Phiri MM, Sigande L, Schaap A, Simuyaba M, Zulu-Phiri R, Mwape L, Floyd S, Fidler S, Hayes R, Simwinga M, Ayles H. Self-reported uptake of STI testing services among adolescents and young people aged 15-24 years: Findings from the Yathu Yathu cluster randomized trial in Lusaka, Zambia. PLOS Glob Public Health. 2024 Mar 4;4(3):e0002491. doi: 10.1371/journal.pgph.0002491. eCollection 2024.

    PMID: 38437238DERIVED

  • Hensen B, Floyd S, Phiri MM, Schaap A, Sigande L, Simuyaba M, Mwenge L, Zulu-Phiri R, Mwape L, Fidler S, Hayes R, Simwinga M, Ayles H. The impact of community-based, peer-led sexual and reproductive health services on knowledge of HIV status among adolescents and young people aged 15 to 24 in Lusaka, Zambia: The Yathu Yathu cluster-randomised trial. PLoS Med. 2023 Apr 21;20(4):e1004203. doi: 10.1371/journal.pmed.1004203. eCollection 2023 Apr.

    PMID: 37083700DERIVED

  • 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.

    PMID: 35421966DERIVED

  • 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.

    PMID: 34325696DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Interventions

Reproductive Health Services

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Helen Ayles

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 19, 2019

Study Start

August 3, 2019

Primary Completion

November 5, 2021

Study Completion

March 31, 2022

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

ZA(1)