- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718871
Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study has three specific aims:
Specific Aim 1: Identify key socio-structural factors that frame HIV testing behaviors among clients of Ugandan TH, using an exploratory sequential, mixed-methods study design. First, qualitative interviews with 25-35 purposely-sampled TH clients will characterize the care-seeking trajectory, HIV testing behaviors and related stigma, healthcare costs, and HIV risks and exposures. Based on these results, a survey will be designed and administered to 300 Ugandan adults who utilize TH in Mbarara District. This cross-sectional study will identify 1) rates of HIV testing among TH clients and 2) variables that independently predict HIV testing within the prior 12 months. These data will inform a model of HIV testing behavior among TH clients based on the Andersen Model of Healthcare Utilization, and generate hypotheses to be tested in Specific Aim 2.
Specific Aim 2: Characterize acceptability of receiving point-of-care (POC) HIV testing at TH locations, using an exploratory sequential, mixed-methods approach. Qualitative interviews with 15-25 purposely sampled TH and 15-25 purposely-sampled TH clients will explore attitudes and experiences with biomedicine, feasibility and acceptability of delivering POC HIV testing at TH locations, and investigate relevant themes emerging from Aim 1. Based on qualitative results, a survey will be developed and administered to 175 TH in Mbarara District. This cross-sectional study will characterize TH practices relevant to HIV testing, and identify characteristics of healers who favorably view the proposed intervention (Specific Aim 3). These data will be integrated with results from SA1 to develop an intervention that will overcome socio-structural barriers to HIV testing.
Specific Aim 3: Develop and pilot an HIV testing intervention among TH clients using a cluster randomized study design. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 9 TH practice locations, to be compared with a control group receiving usual TH care at 8 practices. This pilot will offer HIV testing at TH practice sites to 250 TH clients at the intervention arm sites, and offer protocoled usual care to 250 clients at control arm sites. Primary outcome for this study will be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new HIV diagnoses among TH clients, and ii) number of patients with +HIV POC test who successfully link to HIV care in 3 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mbarara, Uganda
- Mbarara University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 year of age or older
- able to provide informed consent
- not known to be HIV infected
- willing to be contacted at 3 months following enrollment
- willing to complete an exit survey after 3 months
Exclusion Criteria:
- being under the age of 18 years
- incapable of giving informed consent
- previously being diagnosed with HIV
- being unwilling to receive HIV test results
- unwilling to participate in the testing intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healer HIV testing intervention
We will follow Ugandan National protocols to administer voluntary HIV testing at 9 TH practice locations throughout Mbarara District over a 9 month period.
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HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test.
Pre-test counseling will be performed before results are delivered.
Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care.
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No Intervention: Healer control arm
Patients will undergo protcolized usual TH care at 8 practices, which include HIV education and a referral to receive VCT through existing resources.
Study staff will contact the client at 3 months following enrollment to assess for self-report of VCT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of TH Clients Who Received HIV Testing
Time Frame: within 3 months following study visit
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Primary study outcome was receipt of an HIV test within 90 days of enrollment.
In the control arm, this was assessed via self-report at time of 90-day phone call follow up.
For intervention arm, the participating healer recorded whether an HIV test was accepted by the participant at the time of the study visit.
If the HIV test was accepted and delivered, the healer recorded the result of the test.
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within 3 months following study visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of New HIV Diagnoses Among TH Clients
Time Frame: within three months following enrollment.
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For intervention arm participants, the healer recorded the result of the point-of-care HIV test for those participants who agreed to test during the study visit.
In the control arm, this outcomes was assessed via self-report during the 90-day follow up phone call.
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within three months following enrollment.
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Number of Patients With +HIV Test Who Successfully Link to HIV Care
Time Frame: at three months following enrollment.
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This outcome was assessed via self-report during the 90-day follow up phone call.
For participants newly testing HIV-positive, questions were posed to determine if they had received confirmatory testing, and initiated ART medication.
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at three months following enrollment.
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Age in Years of Control Arm Subjects Who Received an HIV Test
Time Frame: 3 months following study enrollment
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Participants in the control arm assessed for primary outcomes of receiving an HIV test within 3 months of study enrollment.
Participant age in years at time of study enrollment, and association with primary outcome of receiving an HIV test
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3 months following study enrollment
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Gender of Control Arm Subjects Who Received an HIV Test
Time Frame: at 3 months following enrollment
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Self-reported participant gender and association with primary study outcome of receiving an HIV test
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at 3 months following enrollment
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Highest Level of Education for Control Arm Subjects Who Received an HIV Test
Time Frame: at 3 months following study enrollment
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Participant self-reported highest level of education, and association with study primary outcome of receiving an HIV test
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at 3 months following study enrollment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Radhika Sundararajan, MD, PhD, Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1803019105
- K23MH111409 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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