Clinical trial NCT03719521: Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe
Official title: Community Based Interventions to Improve HIV Outcomes in Youth: a Cluster Randomised Trial in Zimbabwe (CHIEDZA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: Adolescents
Youth
Sexual and reproductive health
Africa
community-based
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Biomedical Research and Training Institute
First posted: 2018-10-25
Enrollment: 36991
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial
Primary purpose: OTHER

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.

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

Eligibility criteria: Inclusion Criteria:

* Reside within cluster boundaries
* Aged 16 to 24 years

Exclusion Criteria:

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

Primary outcomes:
measure: Viral suppression among HIV-positive individuals
timeFrame: Measured after the 30 months of intervention.
Secondary outcomes:
measure: Knowledge of HIV-positive status
timeFrame: After 30 months of intervention
measure: Coverage of antiretroviral therapy (ART) among those who their positive HIV status
timeFrame: After 30 months of the intervention
measure: Viral suppression among those who report taking ART
timeFrame: After 30 months of the intervention
Other outcomes:
Locations:
city: Marondera
country: Zimbabwe
facility: Mashonaland East Province
state: Mashonaland East
city: Bulawayo
country: Zimbabwe
facility: Bulawayo Province
city: Harare
country: Zimbabwe
facility: Harare Province
Study officials:
affiliation: LondonSchool Of Hygiene and Tropical Medicine
name: Rashida Ferrand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.