Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/9/2018 |
| Start Date: | July 30, 2018 |
| End Date: | January 2022 |
| Contact: | Jessica F Magidson, PhD |
| Email: | jmagidso@umd.edu |
| Phone: | 301-405-5095 |
Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
The purpose of this study is to test the effectiveness and implementation of a brief,
integrated behavioral intervention for HIV medication adherence and substance use in the HIV
care setting in South Africa. The intervention is specifically designed to be implemented by
non-specialist counselors using a task sharing model in local HIV clinics. The behavioral
intervention will be compared to usual care, enhanced with referral to a local outpatient
substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as
described in study endpoint section below).
integrated behavioral intervention for HIV medication adherence and substance use in the HIV
care setting in South Africa. The intervention is specifically designed to be implemented by
non-specialist counselors using a task sharing model in local HIV clinics. The behavioral
intervention will be compared to usual care, enhanced with referral to a local outpatient
substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as
described in study endpoint section below).
The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large
antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which
increases the likelihood of developing drug resistance and failing the only available first
and second line ART regimens in SA. ART nonadherence contributes to greater morbidity,
mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the
same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and
associated with worse ART adherence, lower rates of viral suppression, and HIV transmission
risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment
outcomes and continued HIV transmission, there is little if any integration of substance use
and HIV care services in SA, which creates a fragmented and incomplete system of care. This
study had three phases, first being formative, qualitative work which led to a systematic
treatment adaptation phase. This third phase, the clinical trial, is based on this formative
work and other empirical support using behavioral interventions to improve ART adherence and
reduce substance use in resource-limited settings, including SA. This study is a Type 1
hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral
intervention for adherence and substance use integrated into the HIV primary care setting in
SA. To ensure that those who need this intervention most will receive it, participants will
be patients with HIV who are struggling with adherence (as defined in the investigator's
inclusion criteria) and who have an elevated substance use risk.
antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which
increases the likelihood of developing drug resistance and failing the only available first
and second line ART regimens in SA. ART nonadherence contributes to greater morbidity,
mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the
same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and
associated with worse ART adherence, lower rates of viral suppression, and HIV transmission
risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment
outcomes and continued HIV transmission, there is little if any integration of substance use
and HIV care services in SA, which creates a fragmented and incomplete system of care. This
study had three phases, first being formative, qualitative work which led to a systematic
treatment adaptation phase. This third phase, the clinical trial, is based on this formative
work and other empirical support using behavioral interventions to improve ART adherence and
reduce substance use in resource-limited settings, including SA. This study is a Type 1
hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral
intervention for adherence and substance use integrated into the HIV primary care setting in
SA. To ensure that those who need this intervention most will receive it, participants will
be patients with HIV who are struggling with adherence (as defined in the investigator's
inclusion criteria) and who have an elevated substance use risk.
Inclusion Criteria:
- HIV positive and on ART
- 18-65 years of age
- Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or
greater than or equal to 11 for alcohol)
- Have at least one of the following:
1. Not attained viral suppression from first line ART (VL>400 copies/mL)
2. On second-line ART treatment
3. Reinitiated first-line treatment within the past three months
4. Had a pharmacy non-refill at least once in the past 3 months
Exclusion Criteria:
- Inability to provide informed consent or complete procedures in English or isiXhosa
- Severe risk/likely dependence for opiates (ASSIST score >26) because opiate
substitution therapy may not be available
- Severe alcohol dependence symptoms that may warrant medical management of potential
withdrawal symptoms
- Active, untreated, major mental illness (with untreated psychosis or mania) that would
interfere with the paraprofessional adapted intervention
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