HIV InfectionsNCT04060420
Yathu Yathu: An Impact Evaluation of Community-based Peer-led Sexual and Reproductive Health Services
A study testing Comprehensive sexual and reproductive health services in people with HIV Infections and Sexually Transmitted Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Comprehensive sexual and reproductive health services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteZambia
- Study dates
- 3 Aug 2019to 31 Mar 2022
- 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 16 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Comprehensive sexual and reproductive health services
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of HIV status
Defined as self-reported HIV positive status or reporting an HIV-test within the previous 1 year period.
Measured: Outcome measured at single time point, but refers to previous 1 year period.
Secondary outcomes (6)
Coverage of sexual and reproductive health services
The average number of services accessed at least once the previous 1 year period.
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
Uptake of medical male circumcision services
Proportion of adolescent boys and young men accessing voluntary medical male circumcision services
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
Met need for family planning
Proportion of young women with met needs for family planning services
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
PrEP uptake and adherence
Self-reported uptake of and adherence to PrEP among individuals who are HIV negative
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
ART use
Self-reported current use of and retention on ART among individuals who are HIV positive
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
Pregnancies among young women
Proportion of young women reporting pregnancy
Measured: Outcome measured at single time point, but refers to the previous 1 year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start3 Aug 2019
- Primary completion5 Nov 2021
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zambart, Imperial College London, Medical Research Council (funder; grant number: MR/R022216/1)
- Responsible party
- Sponsor
- Investigators
- Helen Ayles, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060420
- Sponsor's protocol ID
- 17104
- Status last verified
- Nov 2021
- First submitted
- 12 Aug 2019
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41225474Phiri 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.
PubMed 38807091Hensen 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.
PubMed 38437238Hensen 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.
PubMed 37083700Phiri 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.
PubMed 35421966Simuyaba 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.
PubMed 34325696
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04060420
- Acronym / sponsor ID
- 17104
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Zambart, Imperial College London, Medical Research Council (funder; grant number: MR/R022216/1)
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Aug 2019 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive sexual and reproductive health services | Experimental | Other: Comprehensive sexual and reproductive health servicesIn 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. |
| 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. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Comprehensive sexual and reproductive health servicesThe 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. | Other | Comprehensive sexual and reproductive health services |
Primary outcome
Knowledge of HIV status
Time frame: Outcome 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.
6 secondary outcomes
Coverage of sexual and reproductive health services
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
Uptake of medical male circumcision services
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
Met need for family planning
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
PrEP uptake and adherence
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
ART use
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
Pregnancies among young women
Time frame: Outcome measured at single time point, but refers to the previous 1 year period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 41225474Rotsaert 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.
- Derived from this study: PubMed 38807091Phiri 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.
- Derived from this study: PubMed 38437238Hensen 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.
- Derived from this study: PubMed 37083700Hensen 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.
- Derived from this study: PubMed 35421966Phiri 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.
- Derived from this study: PubMed 34325696Simuyaba 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.
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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.
Helen Ayles principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive sexual and reproductive health services in people with HIV Infections and Sexually Transmitted Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
Results are not available in the source record.
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?
Knowledge of HIV status (time frame: Outcome measured at single time point, but refers to previous 1 year period.). 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 NCT04060420, which also lists 6 linked publications.
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 24 Nov 2021.