Clinical trial NCT02497456: The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Official title: The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Counselling
Care
antiretroviral therapy
linkage
Uganda
Africa
Lead sponsor: MRC/UVRI and LSHTM Uganda Research Unit
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2015-07-14
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: The time between HIV diagnosis and linkage to pre-ART care.
timeFrame: 6 months
Secondary outcomes:
measure: Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
timeFrame: 6 months
measure: The time between learning that a participant is eligible for ART and ART initiation
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
measure: The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
timeFrame: 6 months
Locations:
city: Masaka
country: Uganda
facility: MRC/UVRI Uganda Research Unit on Aids
Study officials:
affiliation: MRC/UVRI and LSHTM Uganda Research Unit
name: Eugene Ruzagira
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.