Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02545673
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2015
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Makerere University
University of Connecticut
Harvard School of Public Health
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan M. Kiene, San Diego State University

Brief Summary:
The purpose of this study is to evaluate the effectiveness of a linkage to care intervention at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural Uganda.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Enhanced linkage to care Behavioral: Standard-of-care plus Not Applicable

Detailed Description:

Throughout sub-Saharan Africa there is a pressing need to facilitate early and easier entry into HIV care and treatment; up to two-thirds of patients are lost to follow up between testing HIV positive and initiation of antiretroviral (ARV) treatment. Home-based HIV testing and counseling (HBHCT), which identifies those who are HIV positive at earlier disease stages than other testing approaches, is becoming a large component of many sub-Saharan African countries' HIV prevention programs, including Uganda's. Paper-based referral to care, sometimes adding follow-up home visits, is the most common linkage-to-care approach with HBHCT. Linkage to care may be challenging with HBHCT since the testing occurs in the home at a distance from a health facility. The investigators propose to test an intervention which enhances a linkage to care intervention tested in an urban Ugandan provider-initiated HIV testing setting and found to improve linkage to care. The aims of the project are: (1) In a cluster randomized trial compare the effectiveness of the enhanced linkage to care intervention vs. standard-of-care (paper based referrals) at achieving HIV viral suppression and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and ART initiation among those eligible for antiretroviral therapy (ART). (2) Using the standard-of-care group as a natural history control, collect longitudinal data on barriers to and facilitators of linkage to and retention in care and treatment and HIV viral suppression. (3) Estimate the cost-effectiveness of the intervention, as compared to standard-of-care, in terms of major study outcomes.

Participation in the full study will last 12 months. All participants will first undergo HBHCT, viral load and CD4 testing, and complete a brief questionnaire. Participants will then be randomly assigned to one of two study arms: the enhanced linkage to care intervention arm or the standard-of-care control arm. Participants in both study arms will participate in interviewer administered questionnaires at 6 months and 12 months follow-up, viral load and CD4 testing at 12 month follow-up, and will permit the research team to access their medical records to extract information about their health status and linkage to care. Participants in the intervention arm will also receive a series of counseling sessions with an HIV counselor taking place at the participant's home, clinic, and over the phone. These sessions will last approximately 30 minutes, and consist of counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Enhanced Linkage
Participants will receive the enhanced linkage to care Intervention. Behavioral: Enhanced linkage to care Intervention Multiple sessions will focus on providing orientation to the HIV care system, counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support. The approach is guided by the HIV Stigma Framework.
Behavioral: Enhanced linkage to care
Active Comparator: Standard-of-care plus
Behavioral: Participants will receive the standard-of-care (paper-based referrals) plus return of CD4 test results to their home.
Behavioral: Standard-of-care plus



Primary Outcome Measures :
  1. HIV Viral load suppression [ Time Frame: 12 months follow up ]
    defined as HIV RNA <20 cells/ml) collected via venous blood draw


Secondary Outcome Measures :
  1. Linkage to HIV care [ Time Frame: 6 and 12 months follow up ]
    Enrollment in an HIV clinic with a 2nd clinic visit

  2. Time to HIV care [ Time Frame: 6 and 12 months follow up ]
    Time from HIV testing to enrollment in an HIV clinic

  3. Receipt of co-trimoxazole [ Time Frame: 6 and 12 months follow up ]
    The percentage of participants who received co-trimoxazole

  4. Time to receipt of co-trimozazole [ Time Frame: 6 and 12 months follow up ]
    Time to receipt of co-trimoxazole

  5. Receipt of ART [ Time Frame: 6 and 12 months follow up ]
    Percentage of eligible participants receiving ART

  6. Time to receipt of ART [ Time Frame: 6 and 12 months follow up ]
    Time from HIV testing to receipt of ART

  7. Short-term retention in care: Missed visits [ Time Frame: 6 and 12 months follow up ]
    Missed visit count: number of missed visits accrued (count measure) based on scheduled visits determined by Ministry of Health clinical guidelines

  8. Short-term retention in care: Proportion of kept visits/scheduled visits [ Time Frame: 6 and 12 months follow up ]
    Proportion of kept visits/scheduled visits (kept + missed visits)

  9. Short-term retention in care: 4 month visit constancy [ Time Frame: 6 and 12 months follow up ]
    4-month constancy 4 month visit constancy: number of 4-month intervals with at least 1 kept visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion for home-based HIV counseling and testing and brief baseline questionnaire:

Inclusion Criteria:

• 18-59 years of age or an emancipated minor

Exclusion Criteria:

  • not a resident of the household
  • Does not speak Luganda or English

Inclusion/Exclusion for the Intervention Study:

Inclusion criteria:

  • participated in the baseline interview and home-based HIV counseling and testing,
  • newly diagnosed HIV positive in the home-based HIV counseling and testing

Exclusion criteria:

• Other household members also newly diagnosed as HIV positive. Only one newly diagnosed HIV positive person per household will be included


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): NCT02545673


Locations
Layout table for location information
Uganda
Butambala, Mpigi, Mityana, Gomba Districts
Gombe, Uganda
Sponsors and Collaborators
Susan M. Kiene
Makerere University
University of Connecticut
Harvard School of Public Health
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Susan M. Kiene, PhD San Diego State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Susan M. Kiene, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT02545673     History of Changes
Other Study ID Numbers: UG2015_01
R01MH106391 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Susan M. Kiene, San Diego State University:
Intervention Studies
Access to Health Care
Social Stigma
Social Support