Mobile Health Intervention to Reduce HIV Transmission

A Randomized Trial of Behaviorally Enhanced HIV Treatment as Prevention (B-TasP)

Seth C. Kalichman, PhD; Chauncey Cherry, PhD; Moira O. Kalichman, MSW; Lisa A. Eaton, PhD; James J. Kohler, PhD; Catherine Montero, BS; Raymond F. Schinazi, PhD, DSc

Disclosures

J Acquir Immune Defic Syndr. 2018;78(1):34-42. 

In This Article

Abstract and Introduction

Abstract

Objectives: We conducted a randomized clinical trial to test a mobile health behavioral intervention designed to enhance HIV treatment as prevention (B-TasP) by simultaneously increasing combination antiretroviral therapies (cART) adherence and improving the sexual health of people living with HIV.

Methods: A cohort of sexually active men (n = 383) and women (n = 117) living with HIV were enrolled. Participants were baseline assessed and randomized to either (1) B-TasP adherence and sexual health intervention or (2) general health control intervention. Outcome measures included HIV RNA viral load, cART adherence monitored by unannounced pill counts, indicators of genital tract inflammation, and sexual behaviors assessed over 12 months.

Results: Eighty-six percent of the cohort was retained for 12-month follow-up. The B-TasP intervention demonstrated significantly lower HIV RNA, OR = 0.56, P = 0.01, greater cART adherence, Wald χ2 = 33.9, P = 0.01, and fewer indicators of genital tract inflammation, Wald χ2 = 9.36, P = 0.05, over the follow-up period. Changes in sexual behavior varied, with the B-TasP intervention showing lower rates of substance use in sexual contexts, but higher rates of condomless sex with non-HIV positive partners occurred in the context of significantly greater beliefs that cART reduces HIV transmission.

Conclusions: Theory-based mobile health behavioral interventions can simultaneously improve cART adherence and sexual health in people living with HIV. Programs aimed to eliminate HIV transmission by reducing HIV infectiousness should be bundled with behavioral interventions to maximize their impact and increase their chances of success.

Introduction

The success of combination antiretroviral therapies (cART) in suppressing viral replication has transformed HIV infection from a life-threatening disease with 100% mortality into a chronic, long-term, medically manageable condition. There is definitive evidence that sustained HIV suppression in the absence of genital tract inflammation (GTI), principally caused by sexually transmitted coinfections (STI), nearly eliminates the risk of HIV transmission.[1–6] Increasing cART coverage can reduce HIV infections at the population-level by as much as 50%,[7] and the potential impact of treatment on slowing HIV epidemics has led to ambitious policies to eliminate HIV infections, particularly the WHO's 90–90-90 initiative.[8] The success of cART-based prevention strategies, known as treatment as prevention (TasP), are however limited by nonadherence and untreated STI. Poor linkage to care, cART nonadherence and background GTI may account for the failure of efforts to scale-up cART to achieve reductions in HIV transmission in some settings.[9,10]

The correlation between HIV RNA in various compartments (ie, blood plasma and genital tract fluids) is low[11,12] and seems dependent on specific cART regimens, drug penetration into the genital tract immune compartment, and patient adherence. In addition, local viral shedding caused by inflammatory processes[13,14] can further suppress the correlation between viral RNA in blood plasma verses genital track fluid. Sexual risks for STI are linked to cART nonadherence by a cluster of common determinants, including conditions of poverty, substance use, and mental health problems.[15–18] Behavioral interventions aimed at simultaneously increasing cART adherence and reducing sources of GTI may therefore enhance the impact of TasP.[19,20]

Effective interventions for improving cART adherence focus on cognitive-behavioral skills and strategies to resolve individual, situational, and structural barriers.[21] Cognitive-behavioral skill-building techniques are also central to the most effective sexual health interventions,[22,23] which focus on preventing and treating sources of GTI, particularly STI. Both controlling HIV replication in blood plasma with suppressive cART and avoiding genital tract activation of leukocytes that stimulate HIV shedding[24] can synergize to reduce HIV transmission. Unfortunately, few studies have tested integrative approaches to simultaneously increase cART adherence and improve sexual health of people living with HIV.

The Centers for Disease Control and Prevention's Compendium of Evidence-Based Interventions includes 1 behavioral intervention designed for use with TasP.[25] The intervention is grounded in cognitive-behavioral skill building and aims to resolve challenges to accessing care, adhering to cART, and maintaining sexual health through condom use and engaging with sexual health services.[26] The integrated adherence-sexual health intervention included elements found in previous interventions that targeted adherence and sexual health separately.[27,28] Results showed that the integrated intervention significantly reduced HIV viral load, increased cART adherence, and reduced new STI diagnoses. Despite promising outcomes, the CDC disseminated integrated adherence-sexual health intervention requires multiple facility-based small group sessions, making it an effective intervention of limited use. By contrast, mobile health (mHealth) interventions have the flexibility and reach to overcome the challenges of repeated visits to a clinic or other facilities. Although mHealth interventions are generally believed to improve access to care for patients living in rural areas, advances in telecommunications also remove barriers to care such as stigma-related concerns, time constraints, and lack of transportation that patients in urban centers also face. Behavioral health interventions are adaptable to fit low-cost mHealth platforms and thereby expand access to evidence-based services.[29] Here, we report the outcomes of a randomized clinical trial designed to test the effects of an mHealth adaptation of the CDC disseminated integrated cART adherence and sexual health intervention to behaviorally enhance TasP (B-TasP).[26]

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