Clinical trial NCT03529409: Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa
Official title: Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Alcohol-Related Disorders
Drug Use
Keywords: Immunologic Deficiency Syndromes
Substance Use
Acquired Immunodeficiency Syndrome
Immune System Diseases
Behavioral Symptoms
RNA Virus Infections
HIV Infections
Alcohol Use
Drug Use
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-05-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in HIV Medication Adherence Throughout Intervention Phase
timeFrame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Biological Measure of Substance Use
timeFrame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Biological Measure of Substance Use
timeFrame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Changes in Self-reported Substance Use
timeFrame: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Secondary outcomes:
measure: Biological Measure of Substance Use
timeFrame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
measure: Biological Measure of Substance Use
timeFrame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
measure: Changes in Self-reported Substance Use
timeFrame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
measure: Intervention Acceptability
timeFrame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Intervention Feasibility
timeFrame: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Intervention Fidelity
timeFrame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
measure: Intervention Uptake
timeFrame: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Other outcomes:
measure: HIV Viral Load
timeFrame: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
measure: Changes in Self-reported Substance Use
timeFrame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
measure: Changes in Self-reported Substance Use
timeFrame: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: University of Maryland
name: Jessica F Magidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belus JM, Rose AL, Andersen LS, Ciya N, Joska JA, Myers B, Safren SA, Magidson JF. Adapting a Behavioral Intervention for Alcohol Use and HIV Medication Adherence for Lay Counselor Delivery in Cape Town, South Africa: A Case Series. Cogn Behav Pract. 2022 May;29(2):454-467. doi: 10.1016/j.cbpra.2020.10.003. Epub 2020 Nov 10.
citation: Belus JM, Joska JA, Bronsteyn Y, Rose AL, Andersen LS, Regenauer KS, Myers B, Hahn JA, Orrell C, Safren SA, Magidson JF. Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa. AIDS Behav. 2022 Nov;26(11):3630-3641. doi: 10.1007/s10461-022-03765-8. Epub 2022 Jul 27.
citation: Magidson JF, Joska JA, Belus JM, Andersen LS, Regenauer KS, Rose AL, Myers B, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25720. doi: 10.1002/jia2.25720.
citation: Magidson JF, Joska JA, Myers B, Belus JM, Regenauer KS, Andersen LS, Majokweni S, O'Cleirigh C, Safren SA. Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa. Implement Sci Commun. 2020;1:23. doi: 10.1186/s43058-020-00004-w. Epub 2020 Mar 4.