Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe
NCT ID: NCT03719521
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36991 participants
INTERVENTIONAL
2019-04-01
2022-06-30
Brief Summary
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Detailed Description
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Aim: The aim is 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 services and general health counselling for 16 to 24 year olds on population level HIV viral load in a high HIV prevalence setting.
Design: This is a two-arm cluster-randomised trial in 24 clusters randomised 1:1 to standard of care or to the intervention package.
Intervention: Community-based package of services that includes: HIV testing and counselling, delivery of antiretroviral therapy, adherence support groups, mobile health, condoms, menstrual hygiene management, contraception and treatment of sexually transmitted infections, referral for voluntary medical male circumcision and cervical screening, risk reduction counselling and general health information and counselling. The intervention will be implemented over a two and half year period. The intervention will be implemented in 12 clusters, each with a population of approximately 2500-4000 16-24 year olds.
Study Outcomes: The study outcomes will be determined at a population level through a community cross-sectional survey among 18 to 24 year olds two years following the implementation of the intervention. The primary outcome is the proportion with HIV with a viral load \<1000 copies/ml. The secondary outcomes will reflect each step of the HIV care cascade: proportion with HIV who know their HIV status, proportion of those who know their HIV-positive status who are currently taking antiretroviral therapy, proportion of those taking antiretroviral therapy who are virally suppressed. Sexual and reproductive health knowledge, risks and behaviour will also be assessed.
Study population: The end-line survey will recruit 700 18-24 year olds per cluster (total 16 800).
Study sites: The study will be conducted in 3 provinces in Zimbabwe: Harare, Bulawayo and Mashonaland East.
Study Duration: The planned duration of the entire study will be 4 years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention Arm
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.
Community-based package of integrated HIV, SRH and general health services
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
Control Arm
Routine existing services
Community-based package of integrated HIV, SRH and general health services
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
Interventions
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Community-based package of integrated HIV, SRH and general health services
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 16 to 24 years
Exclusion Criteria
* Aged below 16 years
* Aged above 24 years
16 Years
24 Years
ALL
Yes
Sponsors
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Biomedical Research and Training Institute
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Rashida Ferrand, PhD
Role: PRINCIPAL_INVESTIGATOR
LondonSchool Of Hygiene and Tropical Medicine
Locations
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Mashonaland East Province
Marondera, Mashonaland East Province, Zimbabwe
Bulawayo Province
Bulawayo, , Zimbabwe
Harare Province
Harare, , Zimbabwe
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16124
Identifier Type: -
Identifier Source: org_study_id
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