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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    24000
  • sponsor
    London School of Hygiene and Tropical Medicine
Updated on 23 January 2021
hiv test
hiv viral load
HIV Vaccine

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.

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-year period. The intervention will be implemented in 12 clusters, each with a population of approximately 2500 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 1000 18-24 year olds per cluster (total 24,000).

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

Details
Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Treatment Community-based package of integrated HIV, SRH and general health services
Clinical Study IdentifierNCT03719521
SponsorLondon School of Hygiene and Tropical Medicine
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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