NCT03719521

Brief Summary

A cluster randomised trial to determine the impact of an integrated community-based package of HIV services incorporating HIV testing, linkage to care and ongoing adherence support, combined with sexual and reproductive health (SRH) services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36,991

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 17, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

3.2 years

First QC Date

October 17, 2018

Last Update Submit

January 25, 2023

Conditions

HIV Infection

Keywords

AdolescentsYouthSexual and reproductive healthAfricacommunity-based

Outcome Measures

Primary Outcomes (1)

  • Viral suppression among HIV-positive individuals

    % of those with HIV with an HIV viral load \<1000 copies /ml

    Measured after the 30 months of intervention.

Secondary Outcomes (3)

  • Knowledge of HIV-positive status

    After 30 months of intervention

  • Coverage of antiretroviral therapy (ART) among those who their positive HIV status

    After 30 months of the intervention

  • Viral suppression among those who report taking ART

    After 30 months of the intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Community-based provision of an integrated package of services over a 24 month period. For all those aged 16-24 years residing in the intervention clusters: HIV testing, Sexual and reproductive health services (condoms, menstrual hygiene management, contraception, syndromic sexually transmitted infection (STI) treatment, referral for voluntary medical male circumcision, cervical screening), General health information and counselling. For those who are aged 16-24 years and test HIV-positive (or known HIV positive) within the intervention clusters: ART initiation and community-based treatment, adherence support.

Other: Community-based package of integrated HIV, SRH and general health services

Control Arm

ACTIVE COMPARATOR

Routine existing services

Other: Community-based package of integrated HIV, SRH and general health services

Interventions

Community-based package of integrated HIV, SRH and general health servicesOTHER

HIV Testing and Counselling, SRH and HIV prevention Services and General Health Counselling for all 16-24 year olds and ART initiation and ongoing treatment and adherence support for those who test HIV positive

Also known as: Cluster-randomized trial
Control ArmIntervention Arm

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Reside within cluster boundaries
  • Aged 16 to 24 years

You may not qualify if:

  • Reside outside the cluster boundaries
  • Aged below 16 years
  • Aged above 24 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mashonaland East Province

Marondera, Mashonaland East Province, Zimbabwe

Location

Bulawayo Province

Bulawayo, Zimbabwe

Location

Harare Province

Harare, 242, Zimbabwe

Location

Related Publications (15)

  • Simms V, Dauya E, Dziva Chikwari C, Bandason T, Kranzer K, Tembo M, Mavodza C, Doyle AM, Larsson L, Mugurungi O, Apollo T, Hayes RJ, Ferrand RA; CHIEDZA trial team. Uptake of community-based integrated HIV and sexual and reproductive health services for young people in Zimbabwe: the CHIEDZA study. BMC Health Serv Res. 2025 Nov 10;25(1):1459. doi: 10.1186/s12913-025-13635-3.

    PMID: 41214672DERIVED

  • Ferrand RA, Dauya E, Chikwari CD, Bandason T, Bernays S, Mackworth-Young C, Doyle AM, Grundy C, Indravudh P, Terris-Presholt F, Mavodza CV, Mugurungi O, Apollo T, Ncube G, Larsson L, McCarthy O, Simms V, Tembo M, Kranzer K, Hayes RJ. Integrated community-based HIV and sexual and reproductive health services for youth: a cluster-randomized trial. Nat Med. 2025 Sep;31(9):3081-3088. doi: 10.1038/s41591-025-03762-z. Epub 2025 Jun 24.

    PMID: 40555749DERIVED

  • Kelly SH, Azizi S, Chikwari CD, Tembo M, Bandason T, Dauya E, Mavodza CV, Apollo T, Mugurungi O, Ferrand RA, Simms V. Awareness, access to and uptake of HIV prevention interventions among youth in Zimbabwe: a population-based survey. BMC Infect Dis. 2025 May 16;25(1):709. doi: 10.1186/s12879-025-11076-1.

    PMID: 40380099DERIVED

  • Dziva Chikwari C, Dauya E, Simms V, Kranzer K, Bandason T, Machiha A, Mugurungi O, Musiyandaka P, Mwaturura T, Tshuma N, Bernays S, Mavodza C, Tembo M, Martin K, Mackworth-Young CRS, Busza J, Francis SC, Hayes RJ, Ferrand RA. Effect of a community-based intervention for sexually transmitted infections on population-level prevalence among youth in Zimbabwe (STICH): a cluster-randomised trial. Lancet Glob Health. 2025 Jan;13(1):e134-e145. doi: 10.1016/S2214-109X(24)00373-5. Epub 2024 Nov 14.

    PMID: 39551057DERIVED

  • Hlahla K, Azizi SC, Simms V, Dziva Chikwari C, Dauya E, Bandason T, Tembo M, Mavodza C, Kranzer K, Ferrand R. Prevalence of substance and hazardous alcohol use and their association with risky sexual behaviour among youth: findings from a population-based survey in Zimbabwe. BMJ Open. 2024 Jun 16;14(6):e080993. doi: 10.1136/bmjopen-2023-080993.

    PMID: 38885985DERIVED

  • Martin K, Dauya E, Simms V, Bandason T, Azizi S, Machiha A, Shamu T, Musiyandaka P, Mwaturura T, Francis SC, Mackworth-Young CRS, Busza J, Mavodza C, Tembo M, Hayes RJ, Kranzer K, Ferrand RA, Dziva Chikwari C. Risk factors for curable sexually transmitted infections among youth: findings from the STICH population survey in Zimbabwe. Sex Transm Infect. 2024 Nov 18;100(8):484-491. doi: 10.1136/sextrans-2024-056146.

    PMID: 38871454DERIVED

  • Dziva Chikwari C, Kranzer K, Simms V, Patel A, Tembo M, Mugurungi O, Sibanda E, Mufare O, Ndlovu L, Muzangwa J, Vundla R, Chibaya A, Hayes R, Mackworth-Young C, Bernays S, Mavodza C, Hove F, Bandason T, Dauya E, Ferrand RA. Differentiated care for youth in Zimbabwe: Outcomes across the HIV care cascade. PLOS Glob Public Health. 2024 Feb 21;4(2):e0002553. doi: 10.1371/journal.pgph.0002553. eCollection 2024.

    PMID: 38381752DERIVED

  • Dziva Chikwari C, Dauya E, Bandason T, Tembo M, Mavodza C, Simms V, Mackworth-Young CR, Apollo T, Grundy C, Weiss H, Kranzer K, Mavimba T, Indravudh P, Doyle A, Mugurungi O, Machiha A, Bernays S, Busza J, Madzima B, Terris-Prestholt F, McCarthy O, Hayes R, Francis S, Ferrand RA. The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial. Wellcome Open Res. 2023 Nov 7;7:54. doi: 10.12688/wellcomeopenres.17530.2. eCollection 2022.

    PMID: 38162283DERIVED

  • Mavodza CV, Bernays S, Mackworth-Young CRS, Nyamwanza R, Nzombe P, Dauya E, Chikwari CD, Tembo M, Apollo T, Mugurungi O, Madzima B, Nguwo D, Ferrand RA, Busza J. Fidelity, Feasibility and Adaptation of a Family Planning Intervention for Young Women in Zimbabwe: Provider Perspectives and Experiences. Glob Implement Res Appl. 2023;3(2):182-194. doi: 10.1007/s43477-023-00075-6. Epub 2023 Mar 24.

    PMID: 37293631DERIVED

  • Tembo M, Weiss HA, Larsson LS, Bandason T, Redzo N, Dauya E, Nzanza T, Ishumael P, Gweshe N, Ndlovu P, Dziva Chikwari C, Mavodza CV, Renju J, Francis SC, Ferrand R, Mackworth-Young CRS. A mixed-methods study measuring the effectiveness of a menstrual health intervention on menstrual health knowledge, perceptions and practices among young women in Zimbabwe. BMJ Open. 2023 Mar 9;13(3):e067897. doi: 10.1136/bmjopen-2022-067897.

    PMID: 36894201DERIVED

  • Mavodza CV, Bernays S, Mackworth-Young CRS, Nyamwanza R, Nzombe P, Dauya E, Dziva Chikwari C, Tembo M, Apollo T, Mugurungi O, Madzima B, Kranzer K, Abbas Ferrand R, Busza J. Interrupted Access to and Use of Family Planning Among Youth in a Community-Based Service in Zimbabwe During the First Year of the COVID-19 Pandemic. Stud Fam Plann. 2022 Sep;53(3):393-415. doi: 10.1111/sifp.12203. Epub 2022 Jun 22.

    PMID: 35731634DERIVED

  • Tembo M, Renju J, Weiss HA, Dauya E, Gweshe N, Ndlovu P, Nzombe P, Chikwari CD, Mavodza CV, Mackworth-Young CRS, A Ferrand R, Francis SC. Integration of a menstrual health intervention in a community-based sexual and reproductive health service for young people in Zimbabwe: a qualitative acceptability study. BMC Health Serv Res. 2022 Mar 30;22(1):421. doi: 10.1186/s12913-022-07818-5.

    PMID: 35354445DERIVED

  • Martin K, Dziva Chikwari C, Mackworth-Young CRS, Chisenga M, Bandason T, Dauya E, Olaru ID, Francis SC, Mavodza C, Nzombe P, Nyamwanza R, Hove F, Tshuma M, Machiha A, Kranzer K, Ferrand RA. "It was difficult to offer same day results": evaluation of community-based point-of-care testing for sexually transmitted infections among youth using the GeneXpert platform in Zimbabwe. BMC Health Serv Res. 2022 Feb 10;22(1):171. doi: 10.1186/s12913-022-07557-7.

    PMID: 35144602DERIVED

  • Mavodza CV, Mackworth-Young CRS, Bandason T, Dauya E, Chikwari CD, Tembo M, Apollo T, Ncube G, Kranzer K, Ferrand RA, Bernays S. When healthcare providers are supportive, 'I'd rather not test alone': Exploring uptake and acceptability of HIV self-testing for youth in Zimbabwe - A mixed method study. J Int AIDS Soc. 2021 Sep;24(9):e25815. doi: 10.1002/jia2.25815.

    PMID: 34569710DERIVED

  • Tembo M, Renju J, Weiss HA, Dauya E, Bandason T, Dziva-Chikwari C, Redzo N, Mavodza C, Losi T, Ferrand R, Francis SC. Menstrual product choice and uptake among young women in Zimbabwe: a pilot study. Pilot Feasibility Stud. 2020 Nov 23;6(1):182. doi: 10.1186/s40814-020-00728-5.

    PMID: 33292659DERIVED

MeSH Terms

Conditions

HIV InfectionsCoitus

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehavior

Study Officials

  • Rashida Ferrand, PhD

    LondonSchool Of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Staff conducting the outcome survey will be masked to the arm allocation
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 25, 2018

Study Start

April 1, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Data will be placed in the London School of Hygiene and Tropical Medicine (LSHTM) research data repository. This repository will enable direct download of records with codebooks to enable replication of the data analyses. Data will be anonymised prior to release for data sharing. In addition, annotated questionnaires and STATA do-files used for data cleaning and analysis will be available. All databases will be password-protected and accessible to authorised personnel only. The LSHTM open access repository will also enable access to repository contents through a searchable index.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The study protocol and consent forms will be shared as soon as approved by ethical review boards. The clinical study report will be available on completion of the end line survey and the analytic code will be available 12 months after completion of the study
Access Criteria
Where individual data are concerned, the informed consent procedure will clarify the possibility of use of anonymised data by other researchers. Data users will be required to acknowledge the source of data and to ensure that the regulatory requirements of the Medical Research Council of Zimbabwe and other ethical bodies reviewing the projects are met.
More information

Locations

ZI(3)