HIV Infection
Conditions
Keywords
Adolescents, Youth, Sexual and reproductive health, Africa, community-based
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
Interventions
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
Sponsors
Study design
Masking description
Staff conducting the outcome survey will be masked to the arm allocation
Intervention model description
Community Based Interventions to improve HIV outcomes in youth: a cluster randomised trial
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression among HIV-positive individuals | Measured after the 30 months of intervention. | % of those with HIV with an HIV viral load \<1000 copies /ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of HIV-positive status | After 30 months of intervention | % with an HIV-positive test who know they are HIV-positive |
| Coverage of antiretroviral therapy (ART) among those who their positive HIV status | After 30 months of the intervention | % of those who know their positive HIV status who are currently taking ART |
| Viral suppression among those who report taking ART | After 30 months of the intervention | % of those taking ART who have an HIV viral load \<1000 copies /ml |
Countries
Zimbabwe