The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Follow-up counselling


Participation Criteria
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Eligibility Criteria
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HIV-infected participants Inclusion Criteria: HIV-infected adult (≥18 years) Willing to provide informed consent Willing to receive follow-up counselling at home Exclusion Criteria: Previous or current receipt of HIV care from an ART provider On-going participation in other health-related research Intending to change residence in the next 6 months Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness HIV-uninfected participants Inclusion criteria: HIV negative adult (≥18 years) Willing to provide informed consent Willing to receive follow-up counselling at home Exclusion criteria: Intending to change residence in the next 6 months Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow-up counselling<br>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<br> <br> |
| No Intervention: Standard of care<br>Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Counselling, Care, antiretroviral therapy, linkage, Uganda, Africa