Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial)

Lisa L Abuogi, Maricianah Onono, Thomas A Odeny, Kevin Owuor, Anna Helova, Karen Hampanda, Tobias Odwar, Dickens Onyango, Leslie A McClure, Elizabeth A Bukusi, Janet M Turan, Lisa L Abuogi, Maricianah Onono, Thomas A Odeny, Kevin Owuor, Anna Helova, Karen Hampanda, Tobias Odwar, Dickens Onyango, Leslie A McClure, Elizabeth A Bukusi, Janet M Turan

Abstract

Introduction: Retention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced-based behavioural interventions on postpartum adherence and retention in WLWH in Kenya.

Methods: The Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster-randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty-four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text-messaging, (3) community-based mentor mothers (cMM) or (4) text-messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per-protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions.

Results: We enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost-to-follow-up (LTFU) and 95 (7.1%) were discontinued from the study. In intention-to-treat analyses, the relative risk of being retained at 12-months postpartum was not significantly higher in the intervention arms versus the control arm. In time-to-event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per-protocol analysis, the relative risk of 12-month postpartum retention was 24-29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16-1.32, p<0.001), cMM only RR 1.29 (95% CI 1.21-1.37, p<0.001) and cMM plus text RR 1.29 (1.21-1.37, p<0.001). Women LTFU were younger (p<0.001), less likely to be married (p<0.001) and more likely to be newly diagnosed with HIV during pregnancy (p<0.001). Self-reported ART adherence did not vary by study arm.

Conclusions: Behavioural interventions using peer support and text messages did not appear to improve 12-month postpartum retention and adherence in intention-to-treat analyses. Higher levels of exposure to the interventions may be necessary to achieve the desired effects.

Trial registration: ClinicalTrials.gov NCT02491177.

Keywords: PMTCT; postpartum; retention; viral suppression; women living with HIV.

Conflict of interest statement

None of the authors have competing interests to declare.

LLA, MO, JMT, TAO, KO and EAB conceptualized, designed and conducted the study; analysed and interpreted the data; and drafted the manuscript. TO and DO contributed to study implementation, data collection and interpretation and manuscript writing. LAM provided statistical oversight, data analysis and manuscript review. AH and KH made substantial contributions to interpretation of the results and drafting of the manuscript. All authors read and approved the final manuscript.

© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.

Figures

Figure 1
Figure 1
MOTIVATE study population.
Figure 2
Figure 2
Competing risks regression model of cumulative incidence of proportion of women lost to follow up from delivery to 12 months postpartum by study arm.

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