HIV I Infection
Conditions
Keywords
HIV
Brief summary
Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.
Detailed description
This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.
Interventions
BEHAVIORALUniform Standard of Care Counseling
Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence
BEHAVIORALBehavioral Self-Regulation Skills Counseling
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence.
BEHAVIORALBehavioral Self-Regulation Skills Counseling + Stigma Management
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns.
Sponsors
Medical Research Council, South Africa
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study condition masking
Intervention model description
Behavioral skills training to improve medication adherence
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. current clinic visit to receive cART in differentiated care outside of an adherence club 3. unsuppressed HIV at the most recent clinical testing confirmed in run-in 4. access to a phone
Exclusion criteria
Not meeting inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Records of Care Appointments | 12-months | Medical records are retrospectively collected for all scheduled care visits and coded for whether the visits were attended.The records are exclusively from the clinic where patients are initially recruited and with patient permission. The data obtained are expressed as the ratio of the number of care appointments attended relative to the number scheduled. |
| Blood Plasma RNA | 12-months | Collection of dried blood spots are tested for HIV RNA (viral load) using PCR tests with results expressed as the number of RNA copies per mL of blood plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Medication Adherence | 12-months | Monthly unannounced phone assessments are used to conduct pill counts of antiretroviral medications. The pill counts are used to calculate the proportion of pills taken relative to the number of pills prescribed over a 30 day period. |
Countries
United States
Outcome results
None listed