TY - JOUR

T1 - Project Khanya

T2 - 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

AU - Magidson, Jessica F.

AU - Joska, John A.

AU - Belus, Jennifer M.

AU - Andersen, Lena S.

AU - Regenauer, Kristen S.

AU - Rose, Alexandra L.

AU - Myers, Bronwyn

AU - Majokweni, Sybil

AU - O’Cleirigh, Conall

AU - Safren, Steven A.

N1 - Funding Information: This study was funded by the National Institute of Drug Abuse (NIDA): K23DA041901 (PI: Magidson) and K23DA041901-S1 (Biomarker supplement; PI: Magidson). Dr. Safren?s time was funded by 9K24DA040489, 1P30MH116867 and R01MH103770. Drs. Joska, Andersen and O?Cleirigh were also funded by R01MH103770. Ms. Majokweni was supported by both K23DA041901 and R01MH103770. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, National Institute of Drug Abuse or National Institute of Mental Health. We acknowledge the rest of the Project Khanya team, including but not limited to Nonceba Ciya, Neliswa Kotelo, Sibabalwe Ndamase, Jasper Lee, Emily Satinsky, Hannah Tralka, Christine Wan, and Morgan Anvari and additional mentorship and guidance from Dr. Ashraf Kagee, Warren Burnhams, Dr. David Henderson, Dr. Gregory Fricchione and Dr. Christina Borba. We also acknowledge the City of Cape Town Department of Health for their support and for granting us access to their clinics. We thank the staff, patients and Community Advisory Boards at the Town Two clinic for their time, effort, and support. We would especially like to thank the study participants for their time, input, and contributions to this study. This study was funded by the National Institute of Drug Abuse (NIDA): K23DA041901 (PI: Magidson) and K23DA041901-S1 (Biomarker supplement; PI: Magidson). Dr. Safren?s time was funded by 9K24DA040489, 1P30MH116867 and R01MH103770. Drs. Joska, Andersen and O?Cleirigh were also funded by R01MH103770. Ms. Majokweni was supported by both K23DA041901 and R01MH103770. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, National Institute of Drug Abuse or National Institute of Mental Health. Funding Information: This study was funded by the National Institute of Drug Abuse (NIDA): K23DA041901 (PI: Magidson) and K23DA041901‐S1 (Biomarker supplement; PI: Magidson). Dr. Safren’s time was funded by 9K24DA040489, 1P30MH116867 and R01MH103770. Drs. Joska, Andersen and O’Cleirigh were also funded by R01MH103770. Ms. Majokweni was supported by both K23DA041901 and R01MH103770. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, National Institute of Drug Abuse or National Institute of Mental Health. Publisher Copyright: © 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.

PY - 2021

Y1 - 2021

N2 - Introduction: South Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low-resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes. Methods: A pilot randomized hybrid type 1 effectiveness-implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task-shared, peer-delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on-site AOD treatment. Implementation outcomes, defined by Proctor’s model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post-treatment (three months) measured via real-time electronic adherence monitoring, and AOD measured using biomarker and self-report assessments over six months. Data collection was conducted from August 2018 to April 2020. Results and discussion: Ninety-one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment-by-time interaction for ART adherence (estimate = −0.287 [95% CI = −0.507, −0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self-reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow-back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05). Conclusions: Results of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non-adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task-sharing models for behavioral health in resource-limited, global settings.

AB - Introduction: South Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low-resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes. Methods: A pilot randomized hybrid type 1 effectiveness-implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task-shared, peer-delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on-site AOD treatment. Implementation outcomes, defined by Proctor’s model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post-treatment (three months) measured via real-time electronic adherence monitoring, and AOD measured using biomarker and self-report assessments over six months. Data collection was conducted from August 2018 to April 2020. Results and discussion: Ninety-one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment-by-time interaction for ART adherence (estimate = −0.287 [95% CI = −0.507, −0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self-reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow-back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05). Conclusions: Results of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non-adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task-sharing models for behavioral health in resource-limited, global settings.

KW - antiretroviral therapy adherence

KW - global mental health

KW - HIV

KW - implementation science

KW - South Africa

KW - substance use

U2 - 10.1002/jia2.25720

DO - 10.1002/jia2.25720

M3 - Journal article

C2 - 34164935

AN - SCOPUS:85108546854

VL - 24

JO - International AIDS Society. Journal

JF - International AIDS Society. Journal

SN - 1758-2652

IS - S2

M1 - e25720

ER -