Overcoming Barriers to HIV/AIDS Care and ART Initiation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 315
- Locations
- 1
- Primary Endpoint
- Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
Study Overview
Brief Summary
The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years or older and
- •Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
- •Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
- •Willing to have a CD4 count test conducted at the enrollment visit.
- •Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
- •Willing to be contacted over 1 year to determine if they linked to care.
Exclusion Criteria
- •Previous positive HIV test.
- •Currently taking antiretroviral medications.
- •Currently pregnant (females only).
- •Currently participating in another research study or trial.
- •Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
Arms & Interventions
Standard of care
Standard HIV counseling and referral to care
CD4 testing
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week.
Intervention: Expedited CD4 testing (Behavioral)
CD4 testing plus peer counseling
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
Intervention: Expedited CD4 testing (Behavioral)
CD4 testing plus peer counseling
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
Intervention: Supplemental peer counseling (Behavioral)
Outcomes
Primary Outcomes
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
Time Frame: 1 year
An interviewer administered questionnaire will be used to determine if each participant visited a comprehensive care center. Is so, the date of the first visit will be recorded. From this, the time from enrollment until first visit to a comprehensive care center will be calculated.
Number of days from study enrollment until initiation of antiretroviral therapy.
Time Frame: 1 year
An interviewer administered questionnaire will be used to determine if each participant started antiretroviral therapy. Is so, the date of treatment initiation will be recorded. From this, the time from enrollment until treatment initiation will be calculated.
Secondary Outcomes
- Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.(1 year)
- Measurement of CD4+ T-cell count.(1 year)
Investigators
Brandon Guthrie
Assistant Professor, Global Health
University of Washington