An interventional study of Follow-up counselling in HIV, sponsored by MRC/UVRI and LSHTM Uganda Research Unit. Completed at 1 site in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by MRC/UVRI and LSHTM Uganda Research Unit · Not applicable and Interventional
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.
MRC/UVRI and LSHTM Uganda Research Unit is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-infected participants
Inclusion Criteria:
Exclusion Criteria:
HIV-uninfected participants
Inclusion criteria:
Exclusion criteria:
Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.
Behavioral: Follow-up counselling
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
Time frame: 6 months
The time between HIV diagnosis and linkage to pre-ART care.
Time frame: 6 months
Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
Time frame: 6 months
The time between learning that a participant is eligible for ART and ART initiation
Time frame: 6 months
The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
Time frame: 6 months
The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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MRC/UVRI and LSHTM Uganda Research Unit