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

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ClinicalTrials.gov Identifier: NCT02497456
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
MRC/UVRI Uganda Research Unit on Aids

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Follow-up counselling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: Follow-up counselling
No Intervention: Standard of care
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497456


Locations
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Uganda
MRC/UVRI Uganda Research Unit on Aids
Masaka, Uganda
Sponsors and Collaborators
MRC/UVRI Uganda Research Unit on Aids
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Eugene Ruzagira MRC/UVRI Uganda Research Unit on Aids

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MRC/UVRI Uganda Research Unit on Aids
ClinicalTrials.gov Identifier: NCT02497456     History of Changes
Other Study ID Numbers: Linkage to pre-ART care
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MRC/UVRI Uganda Research Unit on Aids:
HIV
Counselling
Care
antiretroviral therapy
linkage
Uganda
Africa