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

MRC/UVRI and LSHTM Uganda Research Unit338 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

338

Conditions

HIV

Interventions

Follow-up counsellingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

HIV-infected participants Inclusion Criteria: 1. HIV-infected adult (≥18 years) 2. Willing to provide informed consent 3. Willing to receive follow-up counselling at home Exclusion Criteria: 1. Previous or current receipt of HIV care from an ART provider 2. On-going participation in other health-related research 3. Intending to change residence in the next 6 months 4. 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: 1. HIV negative adult (≥18 years) 2. Willing to provide informed consent 3. Willing to receive follow-up counselling at home Exclusion criteria: 1. Intending to change residence in the next 6 months 2. 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

Locations (1)

MRC/UVRI Uganda Research Unit on Aids

Masaka, Uganda

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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