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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up counselling | Experimental | 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. |
|
| Standard of care | No Intervention | Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up counselling | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months | |
| The time between HIV diagnosis and linkage to pre-ART care. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care | 6 months | |
| The time between learning that a participant is eligible for ART and ART initiation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT. | 6 months |
HIV-infected participants
Inclusion Criteria:
Exclusion Criteria:
HIV-uninfected participants
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Ruzagira | MRC/UVRI and LSHTM Uganda Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRC/UVRI Uganda Research Unit on Aids | Masaka | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29052344 | Derived | Ruzagira E, Grosskurth H, Kamali A, Baisley K. Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda. J Int AIDS Soc. 2017 Oct;20(2):e25014. doi: 10.1002/jia2.25014. |
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| 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. | 6 months |