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)

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) textmessaging 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.

The effects of revised peer-counselor support on the PMTCT cascade of care: results from a cluster-randomized trial in Kenya (the EMMA study)

“…[ 23 – 26 , 50 – 52 ]. for reviews of such literature; and see [ 11 , 53 ] for additional examples). In short, PMTCT guidelines during the study period (enrollment beginning in 2017) had already incorporated multiple, previously studied improvements in PMTCT care.…”

“…Existing literature has documented a range of typical problems implementing PMTCT services, including late presentation for prenatal care and the lack of retention and/or inconsistent visits before and after delivery [ 11 – 22 ]. These issues then contribute to incomplete viral load testing for mothers and HIV testing for HIV-exposed infant.…”

The effect of a Mentor Mothers program on prevention of vertical transmission of HIV outcomes in Zambézia Province, Mozambique: a retrospective interrupted time series analysis

“…Other studies support MM as an effective strategy for promoting optimal PVT outcomes, but the extent to which MM impact these outcomes has varied between diverse contexts and depends on the content and implementation of MM strategies [ 10 , 11 , 12 , 13 , 14 , 15 ]. Furthermore, findings from the Mother–Infant Visit Adherence and Treatment Engagement study in Kenya indicate that depression, stigma and intimate partner violence modulate PVT outcomes within the context of MM strategies, indicating a need to develop MM strategies that can respond to the specific needs of HIV‐affected mother–infant dyads [ 16 , 17 ]. While protocols for training and supervision of MM were consistent across sites included in this evaluation, we were unable to adjust for individual‐level characteristics or fidelity to MM protocols.…”

Maternal retention and early infant HIV diagnosis in a prospective cohort study of HIV-positive women and their children in Malawi

“…14 Young age, no education, lack of disclosure, recent HIV diagnosis have all been shown to be associated with higher rates of loss to follow-up (LTFU) in studies focusing on determinants of retention. 4,14,15 In our study, although younger women were at higher risk of LTFU, the only independent predictor of loss to follow-up in a multivariable analysis was a short time on ART at enrolment, a factor significantly associated with LTFU also in a large meta-analysis 5 and in one recent study in China. 16 These findings suggest that a more extensive intervention such as specific counselling, active tracing, and home-based assistance should be targeted to the population of recent ART initiators to improve retention.…”