Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments

Conditions
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HIV I Infection

Intervention / Treatment
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* Behavioral: Uniform Standard of Care Counseling
* Behavioral: Behavioral Self-Regulation Skills Counseling
* Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older current clinic visit to receive cART in differentiated care outside of an adherence club unsuppressed HIV at the most recent clinical testing confirmed in run-in access to a phone Exclusion Criteria: Not meeting inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Behavioral skills training to improve medication adherence
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Uniform Standard of Care Counseling<br>Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence. | Behavioral: Uniform Standard of Care Counseling<br>* Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence<br>|
| Active Comparator: Behavioral Self-Regulation Skills Counseling<br>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. | Behavioral: Behavioral Self-Regulation Skills Counseling<br>* 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.<br>|
| Experimental: Behavioral Self-Regulation Skills Counseling + Stigma Management<br>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. | Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Records of Care Appointments | 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. | 12-months | 
| Blood Plasma RNA | 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. | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Medication Adherence | 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. | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV