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