The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
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|ClinicalTrials.gov Identifier: NCT02497456|
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Follow-up counselling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||338 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Follow-up counselling
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
No Intervention: Standard of care
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497456
|MRC/UVRI Uganda Research Unit on Aids|
|Principal Investigator:||Eugene Ruzagira||MRC/UVRI Uganda Research Unit on Aids|