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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02497456
Date of registration: 06/07/2015
Prospective Registration: No
Primary sponsor: MRC/UVRI Uganda Research Unit on Aids
Public title: The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Scientific title: The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Date of first enrolment: March 2015
Target sample size: 338
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02497456
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label  
Phase:  N/A
Countries of recruitment
Uganda
Contacts
Name:     Eugene Ruzagira
Address: 
Telephone:
Email:
Affiliation:  MRC/UVRI Uganda Research Unit on Aids
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
HIV
Intervention(s)
Behavioral: Follow-up counselling
Primary Outcome(s)
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]
The time between HIV diagnosis and linkage to pre-ART care. [Time Frame: 6 months]
Secondary Outcome(s)
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]
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]
The time between learning that a participant is eligible for ART and ART initiation [Time Frame: 6 months]
Secondary ID(s)
Linkage to pre-ART care
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
London School of Hygiene and Tropical Medicine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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