HIV InfectionCHIEDZANCT03719521

Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe

A study testing Community-based package of integrated HIV, SRH and general health services in people with HIV Infection, run by London School of Hygiene and Tropical Medicine at 3 sites in Zimbabwe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 16 to 24 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infection
What is being tested?: Community-based package of integrated HIV, SRH and general health services
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36,991 participants
Where: 3 sitesZimbabwe
Study dates: 1 Apr 2019to 30 Jun 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 24 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Reside within cluster boundaries
Aged 16 to 24 years

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Zimbabwe3 sites

Bulawayo Province
Bulawayo
Harare Province
Harare, 242
Mashonaland East Province
Marondera, Mashonaland East Province

Other trials in Zimbabwe

About this study

Official title: Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe (CHIEDZA)

Read the detailed description

Young people fare disproportionately poorly across the HIV care continuum compared to other age-groups; the prevalence of undiagnosed HIV is substantially higher, and coverage of and adherence to antiretroviral therapy is lower, resulting overall in worse virological outcomes.

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: HIV Infection
Being tested: Community-based package of integrated HIV, SRH and general health services
Keywords: Adolescents, Youth, Sexual and reproductive health, Africa, community-based
Medical subject headings: HIV Infections, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community-based package of integrated HIV, SRH and general health servicesOther
Also called Cluster-randomized trial
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

Study groups in NCT03719521
Study group	Role	What they receive
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. Receives: Other: Community-based package of integrated HIV, SRH and general health services
Control Arm	Active comparator	Routine existing services Receives: Other: Community-based package of integrated HIV, SRH and general health services

What is being measured

The primary outcome is the main question the study is designed to answer.

Viral suppression among HIV-positive individuals
% of those with HIV with an HIV viral load <1000 copies /ml
Measured: Measured after the 30 months of intervention.

Secondary outcomes (3)

Knowledge of HIV-positive status
% with an HIV-positive test who know they are HIV-positive
Measured: After 30 months of intervention
Coverage of antiretroviral therapy (ART) among those who their positive HIV status
% of those who know their positive HIV status who are currently taking ART
Measured: After 30 months of the intervention
Viral suppression among those who report taking ART
% of those taking ART who have an HIV viral load <1000 copies /ml
Measured: After 30 months of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Jun 2022

First posted25 Oct 2018
Study start1 Apr 2019
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 36,991 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03719521
Sponsor's protocol ID: 16124
Acronym: CHIEDZA
Status last verified: Jan 2023
First submitted: 17 Oct 2018
Last updated: 27 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Simms V, Bandason T, Dauya E, Dziva Chikwari C, Grundy C, Tembo M, Mavodza C, Mugurungi O, Apollo T, Ashrafee R, Demetriou D, Sharma A, Hayes RJ, Kranzer K, Ferrand RA. Effectiveness and acceptability of biometrics to evaluate intervention coverage and contamination in a cluster randomised trial of community-based sexual and reproductive health services for youth in Zimbabwe. BMJ Open. 2026 Jul 15;16(7):e107583. doi: 10.1136/bmjopen-2025-107583.
PubMed 42463203
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.
PubMed 41214672
Ferrand RA, Dauya E, Chikwari CD, Bandason T, Bernays S, Mackworth-Young C, Doyle AM, Grundy C, Indravudh P, Terris-Prestholt 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.
PubMed 40555749
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.
PubMed 40380099
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.
PubMed 39551057
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.
PubMed 38885985
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.
PubMed 38871454
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.
PubMed 38381752
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.
PubMed 38162283
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.
PubMed 37293631
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.
PubMed 36894201
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.
PubMed 35731634
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.
PubMed 35354445
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.
PubMed 35144602
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.
PubMed 34569710

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe (CHIEDZA)
ClinicalTrials.gov ID: NCT03719521
Acronym / sponsor ID: CHIEDZA / 16124
Conditions: HIV Infection
Keywords: Adolescents, Youth, Sexual and reproductive health, Africa, community-based
Study type: Interventional
Recruitment status: Completed
Enrolment: 36,991 participants (actual)
Lead sponsor: London School of Hygiene and Tropical MedicineUniversity, hospital or other
Collaborators: Biomedical Research and Training Institute
Study start: 1 Apr 2019 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 25 Oct 2018 (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.

Detailed description

Design: This is a two-arm cluster-randomised trial in 24 clusters randomised 1:1 to standard of care or to the intervention package.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial

Arm	Type	Receives
Intervention Arm	Experimental	Other: Community-based package of integrated HIV, SRH and general health servicesCommunity-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.
Control Arm	Active comparator	Other: Community-based package of integrated HIV, SRH and general health servicesRoutine existing services

Who may qualify

Ages: 16 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Reside within cluster boundaries
Aged 16 to 24 years

Key exclusion criteria (3 listed)

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

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
Community-based package of integrated HIV, SRH and general health servicesAlso: Cluster-randomized trialHIV 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	Control Arm, Intervention Arm

Primary outcome

Viral suppression among HIV-positive individuals
Time frame: Measured after the 30 months of intervention.
% of those with HIV with an HIV viral load <1000 copies /ml

3 secondary outcomes

Knowledge of HIV-positive status
Time frame: After 30 months of intervention
Coverage of antiretroviral therapy (ART) among those who their positive HIV status
Time frame: After 30 months of the intervention
Viral suppression among those who report taking ART
Time frame: After 30 months of the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Derived from this study: PubMed 42463203Simms V, Bandason T, Dauya E, Dziva Chikwari C, Grundy C, Tembo M, Mavodza C, Mugurungi O, Apollo T, Ashrafee R, Demetriou D, Sharma A, Hayes RJ, Kranzer K, Ferrand RA. Effectiveness and acceptability of biometrics to evaluate intervention coverage and contamination in a cluster randomised trial of community-based sexual and reproductive health services for youth in Zimbabwe. BMJ Open. 2026 Jul 15;16(7):e107583. doi: 10.1136/bmjopen-2025-107583.
Derived from this study: PubMed 41214672Simms 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.
Derived from this study: PubMed 40555749Ferrand RA, Dauya E, Chikwari CD, Bandason T, Bernays S, Mackworth-Young C, Doyle AM, Grundy C, Indravudh P, Terris-Prestholt 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.
Derived from this study: PubMed 40380099Kelly 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.
Derived from this study: PubMed 39551057Dziva 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.
Derived from this study: PubMed 38885985Hlahla 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.
Derived from this study: PubMed 38871454Martin 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.
Derived from this study: PubMed 38381752Dziva 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.
Derived from this study: PubMed 38162283Dziva 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.
Derived from this study: PubMed 37293631Mavodza 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.
Derived from this study: PubMed 36894201Tembo 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.
Derived from this study: PubMed 35731634Mavodza 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.
Individual participant dataSharing planned: Yes. 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.

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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.

Rashida Ferrand, PhD principal investigator

LondonSchool Of Hygiene and Tropical Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community-based package of integrated HIV, SRH and general health services in people with HIV Infection, run by London School of Hygiene and Tropical Medicine at 3 sites in Zimbabwe.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Zimbabwe. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Viral suppression among HIV-positive individuals (time frame: Measured after the 30 months of intervention.). 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 NCT03719521, which also lists 16 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 27 Jan 2023.