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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03719521
Other study ID # 16124
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date June 30, 2022

Study information

Verified date January 2023
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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 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


Recruitment information / eligibility

Status Completed
Enrollment 36991
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Zimbabwe Bulawayo Province Bulawayo
Zimbabwe Harare Province Harare
Zimbabwe Mashonaland East Province Marondera Mashonaland East

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Biomedical Research and Training Institute

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Knowledge of HIV-positive status % with an HIV-positive test who know they are HIV-positive After 30 months of intervention
Secondary 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
Secondary 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
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