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Completed

NCT Number: NCT02497456

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRC/UVRI Uganda Research Unit on Aids

Masaka, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up counselling

Behavioral

Primary outcomes

  1. 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

  2. The time between HIV diagnosis and linkage to pre-ART care.

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. The time between learning that a participant is eligible for ART and ART initiation

    Time frame: 6 months

  3. 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

Other outcomes

  1. The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

MRC/UVRI and LSHTM Uganda Research Unit

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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