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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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HIV Infection

Intervention / Treatment
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* Other: Community-based package of integrated HIV, SRH and general health services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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<br>* Other names: Cluster-randomized trial;|
| Active Comparator: Control Arm<br>Routine existing services | Other: Community-based package of integrated HIV, SRH and general health services<br>* 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<br>* Other names: Cluster-randomized trial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of HIV-positive status | % with an HIV-positive test who know they are HIV-positive | 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 | 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 | After 30 months of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Youth, Sexual and reproductive health, Africa, community-based