HIV Clinical Trial
Official title:
The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.
Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through
home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The
few existing data suggest that only 13% to 54% of HIV-infected persons identified through
HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at
improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the
effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care
in Masaka, south-western Uganda.
The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and
follow-up counselling (intervention) compared to referral to pre-ART care only (control),
for individuals diagnosed with HIV through HBHCT. The intervention will be administered at
months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected
on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status
disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and
ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters
(14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the
study to reduce the possibility of revealing the sero-status of the HIV-infected
participants.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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