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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497456
• Other study ID #: Linkage to pre-ART care
• Status: Completed
• Phase: N/A
• First received: July 6, 2015
• Last updated: March 22, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: MRC/UVRI Uganda Research Unit on Aids
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics CommitteeUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Follow-up counselling

Locations

Country	Name	City	State
Uganda	MRC/UVRI Uganda Research Unit on Aids	Masaka

Sponsors (2)

Lead Sponsor	Collaborator
MRC/UVRI Uganda Research Unit on Aids	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.		6 months	No
Primary	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	No
Primary	The time between HIV diagnosis and linkage to pre-ART care.		6 months	No
Secondary	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	No
Secondary	The time between learning that a participant is eligible for ART and ART initiation		6 months	No
Secondary	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	No