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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Follow-up counselling

• Registration Number: NCT02497456
• Lead Sponsor: MRC/UVRI and LSHTM Uganda Research Unit

Brief Summary

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

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Follow-up counselling	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.

Primary Outcome Measures

Name	Time	Method
The time between HIV diagnosis and linkage to pre-ART care.	6 months
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

Secondary Outcome Measures

Name	Time	Method
The time between learning that a participant is eligible for ART and ART initiation	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	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

Trial Locations

Locations (1)

MRC/UVRI Uganda Research Unit on Aids; 🇺🇬 Masaka, Uganda