Randomized Controlled Trial of Rise, A Community-Based Culturally Congruent Counseling Intervention to Support Antiretroviral Therapy Adherence Among Black/African American Adults Living with HIV

Laura M Bogart, Matt G Mutchler, Kathy Goggin, Madhumita Ghosh-Dastidar, David J Klein, Uzaib Saya, Sebastian Linnemayr, Sean J Lawrence, Keshav Tyagi, Damone Thomas, Mahlet Gizaw, Jeff Bailey, Glenn J Wagner, Laura M Bogart, Matt G Mutchler, Kathy Goggin, Madhumita Ghosh-Dastidar, David J Klein, Uzaib Saya, Sebastian Linnemayr, Sean J Lawrence, Keshav Tyagi, Damone Thomas, Mahlet Gizaw, Jeff Bailey, Glenn J Wagner

Abstract

Structural inequities have led to HIV disparities, including relatively low antiretroviral therapy adherence and viral suppression rates among Black Americans living with HIV. We conducted a randomized controlled trial of Rise, a community-based culturally congruent adherence intervention, from January 2018 to December 2021 with 166 (85 intervention, 81 control) Black adults living with HIV in Los Angeles County, California [M (SD) = 49.0 (12.2) years-old; 76% male]. The intervention included one-on-one counseling sessions using basic Motivational Interviewing style to problem solve about adherence, as well as referrals to address unmet needs for social determinants of health (e.g., housing services, food assistance). Assessments included electronically monitored adherence; HIV viral load; and baseline, 7-month follow-up, and 13-month follow-up surveys of sociodemographic characteristics, HIV stigma, medical mistrust, and HIV-serostatus disclosure. Repeated-measures intention-to-treat regressions indicated that Rise led to significantly (two-fold) higher adherence likelihood, lower HIV stigmatizing beliefs, and reduced HIV-related medical mistrust. Effects on HIV viral suppression, internalized stigma, and disclosure were non-significant. Moreover, Rise was cost-effective based on established standards: The estimated cost per person to reach optimal adherence was $335 per 10% increase in adherence. Interventions like Rise, that are culturally tailored to the needs of Black populations, may be optimal for Black Americans living with HIV (ClinicalTrials.gov #NCT03331978).

Keywords: Adherence; Antiretroviral therapy; Black/African American; HIV; Motivational Interviewing; Randomized controlled trial.

Conflict of interest statement

The authors have no relevant financial or non-financial interests to disclose; the authors have no conflicts of interest to declare that are relevant to the content of this article; all authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript; and the authors have no financial or proprietary interests in any material discussed in this article.

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Figures

Fig. 1
Fig. 1
CONSORT diagram of participant flow through the Rise study
Fig. 2
Fig. 2
Percentages of participants with optimal adherence (75% of doses taken, per electronic monitoring) throughout the 13-month study period by treatment condition. The vertical line between 1 and 2 months represents the end of the baseline period, and the vertical line between 7 and 8 months represents the end of the intervention period. Percentages are weighted for presence of adherence data and restricted to the N = 164 included in the model estimating the effect of Rise on adherence

References

    1. Simoni JM, Huh D, Wilson IB, Shen J, Goggin K, Reynolds NR, et al. Racial/ethnic disparities in ART adherence in the United States: findings from the MACH14 study. J Acquir Immune Defic Syndr. 2012;60(5):466–472. doi: 10.1097/QAI.0b013e31825db0bd.
    1. Lyons SJ, Gant Z, Johnson AS, Hu X, Yu C, Jin C, et al. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data: United States and 6 dependent areas, 2018. Center for Disease Control and Prevention; 2021.
    1. Centers for Disease Control and Prevention National Center for HIV VH, STD, and TB Prevention. Fact Sheet: HIV and Black/African American People in the U.S.: U.S. Department of Health & Human Services; 2022. .
    1. Bogart LM, Wagner G, Galvan FH, Banks D. Conspiracy beliefs about HIV are related to antiretroviral treatment nonadherence among African American men with HIV. J Acquir Immune Defic Syndr. 2010;53(5):648. doi: 10.1097/QAI.0b013e3181c57dbc.
    1. Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Longitudinal relationships between antiretroviral treatment adherence and discrimination due to HIV-serostatus, race, and sexual orientation among African-American men with HIV. Ann Behav Med. 2010;40(2):184–190. doi: 10.1007/s12160-010-9200-x.
    1. Dale SK, Bogart LM, Wagner GJ, Galvan FH, Klein DJ. Medical mistrust is related to lower longitudinal medication adherence among African-American males with HIV. J Health Psychol. 2016;21(7):1311–1321. doi: 10.1177/1359105314551950.
    1. Arnold EA, Rebchook GM, Kegeles SM. ‘Triply cursed’: racism, homophobia and HIV-related stigma are barriers to regular HIV testing, treatment adherence and disclosure among young Black gay men. Cult Health Sex. 2014;16(6):710–722. doi: 10.1080/13691058.2014.905706.
    1. Bradley EL, Frazier EL, Carree T, McCree DH, Sutton MY. Psychological and social determinants of health, antiretroviral therapy (ART) adherence, and viral suppression among HIV-positive black women in care. AIDS Care. 2019;31(8):932–941. doi: 10.1080/09540121.2019.1612022.
    1. Centers for Disease Control and Prevention. Compendium of Evidence-Based Interventions and Best Practices for HIV Prevention: Medical Adherence (MA) Chapter: Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention; 2021 [updated January 12, 2022.
    1. Silverman K, Holtyn AF, Rodewald AM, Siliciano RF, Jarvis BP, Subramaniam S, et al. Incentives for viral suppression in people living with HIV: a randomized clinical trial. AIDS Behav. 2019;23(9):2337–2346. doi: 10.1007/s10461-019-02592-8.
    1. Rooks-Peck CR, Wichser ME, Adegbite AH, DeLuca JB, Barham T, Ross LW, et al. Analysis of systematic reviews of medication adherence interventions for persons with HIV, 1996–2017. AIDS Patient Care STDs. 2019;33(12):528–537. doi: 10.1089/apc.2019.0125.
    1. Locher C, Messerli M, Gaab J, Gerger H. Long-term effects of psychological interventions to improve adherence to antiretroviral treatment in HIV-infected persons: a systematic review and meta-analysis. AIDS Patient Care STDs. 2019;33(3):131–144. doi: 10.1089/apc.2018.0164.
    1. HIV Surveillance Annual Report, 2021. Division of HIV and STD Programs Department of Public Health County of Los Angeles; 2022.
    1. Bogart LM, Takada S, Cunningham WE. Medical mistrust, discrimination, and the domestic HIV epidemic. In: Ojikutu BO, Stone VE, editors. HIV/AIDS in US communities of color. New York: Springer; 2019. pp. 207–231.
    1. Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, et al. Project nGage: results of a randomized controlled trial of a dyadic network support intervention to retain young black men who have sex with men in HIV care. AIDS Behav. 2017;21(12):3618–3629. doi: 10.1007/s10461-017-1954-8.
    1. Angelou M. And still i rise. New York: Random House; 1978.
    1. Bogart LM, Mutchler MG, McDavitt B, Klein DJ, Cunningham WE, Goggin KJ, et al. A Randomized controlled trial of Rise, a community-based culturally congruent adherence intervention for Black Americans living with HIV. Ann Behav Med. 2017;51(6):868–878. doi: 10.1007/s12160-017-9910-4.
    1. Wagner GJ, Bogart LM, Mutchler MG, McDavitt B, Mutepfa KD, Risley B. Increasing antiretroviral adherence for HIV-positive African Americans (Project Rise): a treatment education intervention protocol. JMIR Res Protoc. 2016;5(1):e5245. doi: 10.2196/resprot.5245.
    1. Mutchler MG, Wagner G, Cowgill BO, McKay T, Risley B, Bogart LM. Improving HIV/AIDS care through treatment advocacy: going beyond client education to empowerment by facilitating client–provider relationships. AIDS Care. 2011;23(1):79–90. doi: 10.1080/09540121.2010.496847.
    1. Bogart LM, Wagner GJ, Mutchler MG, Risley B, McDavitt BW, McKay T, et al. Community HIV treatment advocacy programs may support treatment adherence. AIDS Educ Prev. 2012;24(1):1–14. doi: 10.1521/aeap.2012.24.1.1.
    1. de Bruin M, Oberjé EJ, Viechtbauer W, Nobel H-E, Hiligsmann M, van Nieuwkoop C, et al. Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial. Lancet Infect Dis. 2017;17(6):595–604. doi: 10.1016/S1473-3099(16)30534-5.
    1. Blackburn NA, Go VF, Bui Q, Hutton H, Tampi RP, Sripaipan T, et al. Implementation of two alcohol reduction interventions among persons with hazardous alcohol use who are living with HIV in Thai Nguyen, Vietnam: a micro-costing analysis. Glob Health Action. 2020;13(1):1814035. doi: 10.1080/16549716.2020.1814035.
    1. Kanouse DE, Bluthenthal RN, Bogart L, Iguchi MY, Perry S, Sand K, et al. Recruiting drug-using men who have sex with men into behavioral interventions: a two-stage approach. J Urban Health. 2005;82(1):i109–i119. doi: 10.1093/jurban/jti030.
    1. Miller WR, Rollnick S. Motivational interviewing: helping people change. New York: Guilford Press; 2012.
    1. Palacio A, Garay D, Langer B, Taylor J, Wood BA, Tamariz L. Motivational interviewing improves medication adherence: a systematic review and meta-analysis. J Gen Intern Med. 2016;31(8):929–940. doi: 10.1007/s11606-016-3685-3.
    1. Dillard PK, Zuniga JA, Holstad MM. An integrative review of the efficacy of motivational interviewing in HIV management. Patient Educ Couns. 2017;100(4):636–646. doi: 10.1016/j.pec.2016.10.029.
    1. Williams G, Rodin G, Ryan R, Grolnick W, Deci E. Autonomous regulation and long-term medication adherence in adult outpatients. Health Psychol. 1998;17(3):269. doi: 10.1037/0278-6133.17.3.269.
    1. Michel KG, Ocampo JMF, Spence AB, Wang C, Kikkisetti A, Doyle A, et al. High provider trust associates with high HIV antiretroviral adherence among women living with HIV in a metropolitan Washington DC Cohort. AIDS Patient Care STDs. 2021;36(1):17–25. doi: 10.1089/apc.2021.0110.
    1. Poteat T, Lassiter JM. Positive religious coping predicts self-reported HIV medication adherence at baseline and twelve-month follow-up among Black Americans living with HIV in the Southeastern United States. AIDS Care. 2019;31(8):958–964. doi: 10.1080/09540121.2019.1587363.
    1. Bogart LM, Wagner GJ, Green HD, Jr, Mutchler MG, Klein DJ, McDavitt B. Social network characteristics moderate the association between stigmatizing attributions about HIV and non-adherence among Black Americans living with HIV: a longitudinal assessment. Ann Behav Med. 2015;49(6):865–872. doi: 10.1007/s12160-015-9724-1.
    1. Chandran A, Benning L, Musci RJ, Wilson TE, Milam J, Adedimeji A, et al. The longitudinal association between social support on HIV medication adherence and healthcare utilization in the women’s interagency HIV study. AIDS Behav. 2019;23(8):2014–2024. doi: 10.1007/s10461-018-2308-x.
    1. Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck J. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, preliminary reliability and validity. Subst Abuse Treat. 2003;65:36–42. doi: 10.1016/j.jsat.2016.01.001.
    1. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Dis. 2009;114(1–3):163–173. doi: 10.1016/j.jad.2008.06.026.
    1. LaVeist TA, Isaac LA, Williams KP. Mistrust of health care organizations is associated with underutilization of health services. Health Serv Res. 2009;44(6):2093–2105. doi: 10.1111/j.1475-6773.2009.01017.x.
    1. Bogart LM, Thorburn S. Are HIV/AIDS conspiracy beliefs a barrier to HIV prevention among African Americans? J Acquir Immune Defic Syndr. 2005;38(2):213–218. doi: 10.1097/00126334-200502010-00014.
    1. Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the internalized AIDS-related stigma Scale. AIDS Care. 2009;21(1):87–93. doi: 10.1080/09540120802032627.
    1. Herek GM, Capitanio JP, Widaman KF. HIV-related stigma and knowledge in the United States: prevalence and trends, 1991–1999. Am J Public Health. 2002;92(3):371–377. doi: 10.2105/AJPH.92.3.371.
    1. Kalichman SC, Simbayi LC, Jooste S, Toefy Y, Cain D, Cherry C, et al. Development of a brief scale to measure AIDS-related stigma in South Africa. AIDS Behav. 2005;9(2):135–143. doi: 10.1007/s10461-005-3895-x.
    1. Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang C-J, et al. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001;33(8):1417–1423. doi: 10.1086/323201.
    1. Bangsberg DR, Hecht FM, Charlebois ED, Chesney M, Moss A. Comparing objective measures of adherence to HIV antiretroviral therapy: electronic medication monitors and unannounced pill counts. AIDS Behav. 2001;5(3):275–281. doi: 10.1023/A:1011396711486.
    1. Byrd KK, Hou JG, Hazen R, Kirkham H, Suzuki S, Clay PG, et al. Antiretroviral adherence level necessary for HIV viral suppression using real-world data. J Acquir Immune Defic Syndr. 2019;82(3):245. doi: 10.1097/QAI.0000000000002142.
    1. Chinn S. A simple method for converting an odds ratio to effect size for use in meta-analysis. Stat Med. 2000;19(22):3127–3131. doi: 10.1002/1097-0258(20001130)19:22<3127::AID-SIM784>;2-M.
    1. Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367(14):1355–1360. doi: 10.1056/NEJMsr1203730.
    1. Goldie SJ, Paltiel AD, Weinstein MC, Losina E, Seage GR, III, Kimmel AD, et al. Projecting the cost-effectiveness of adherence interventions in persons with human immunodeficiency virus infection. Am J Med. 2003;115(8):632–641. doi: 10.1016/j.amjmed.2003.07.007.
    1. Liu H, Miller LG, Hays RD, Golin C, Wu T, Wenger NS, et al. Repeated measures longitudinal analyses of HIV virologic response as a function of percent adherence, dose timing, genotypic sensitivity, and other factors. J Acquir Immune Defic Syndr. 2006;41(3):315–322. doi: 10.1097/01.qai.0000197071.77482.6e.
    1. Dang Q, Mazumdar S, Houck P. Sample size and power calculations based on generalized linear mixed models with correlated binary outcomes. Comput Methods Progr Biomed. 2008;91(2):122–127. doi: 10.1016/j.cmpb.2008.03.001.
    1. Bogart LM, Ojikutu BO, Tyagi K, Klein DJ, Mutchler MG, Dong L, et al. COVID-19 Related medical mistrust, health impacts, and potential vaccine hesitancy among Black Americans living with HIV. J Acquir Immune Defic Syndr. 2021;86(2):200–207. doi: 10.1097/QAI.0000000000002570.
    1. Bogart LM, Barreras JL, Gonzalez A, Klein DJ, Marsh T, Agniel D, et al. Pilot randomized controlled trial of an intervention to improve coping with intersectional stigma and medication adherence among HIV-positive Latinx sexual minority men. AIDS Behav. 2021;25(6):1647–1660. doi: 10.1007/s10461-020-03081-z.
    1. Wijnen BF, Oberjé EJ, Evers SM, et al. Cost-effectiveness and cost-utility of the adherence improving self-management strategy in human immunodeficiency virus care: a trial-based economic evaluation. Clin Infect Dis. 2019;68(4):658–667. doi: 10.1093/cid/ciy553.
    1. Freedberg KA, Hirschhorn LR, Schackman BR, Wolf LL, Martin LA, Weinstein MC, et al. Cost-effectiveness of an intervention to improve adherence to antiretroviral therapy in HIV-infected patients. J Acquir Immune Defic Syndr. 2006;43:S113–S118. doi: 10.1097/01.qai.0000248334.52072.25.
    1. Gross R, Bellamy SL, Chapman J, Han X, O’Duor J, Palmer SC, et al. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013;173(4):300–306. doi: 10.1001/jamainternmed.2013.2152.

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