Clinical trial NCT02491177: Mother and Infant Visit Adherence and Treatment Engagement Study
Official title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV Transmission
Prevention of Mother to Child Transmission
Linkage to care
Retention in care
Community Mentor Mothers
Mobile phone text messaging
Antiretroviral therapy adherence
Infant Health
Maternal CD4/viral loads
Early infant diagnosis
Acceptability of interventions
Vertical transmission
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Kenya Medical Research Institute
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-07-07
Enrollment: 1338
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.

Detailed description: In order to eliminate new pediatric HIV infections, save maternal lives, and simplify antiretroviral therapy (ART) implementation in settings with generalized HIV epidemics, current World Health Organization (WHO) guidance recommends lifelong triple ART for all pregnant and breastfeeding women (Option B+). However, despite the promise of Option B+ to remove logistical barriers and to promote maternal health through life-long ART, this strategy brings challenges. Key amongst these challenges are adherence to ART and continuous retention in HIV care, especially for women who do not require ART for their own health. Barriers to adherence and retention in care for prevention of mother-to-child transmission (PMTCT) have been identified at the individual, interpersonal, community, and health facility levels; yet specific barriers in the context of Option B+ are not well understood. The investigators' study will be conducted at 20 health facilities and associated communities in Nyanza Province, Kenya where Mother to Child Transmission (MTCT) rates prior to Option B+ roll-out remained near 10%, despite the wide availability of PMTCT services. As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond. Building on the investigating team's prior research experience in this setting, the investigators propose to gain understanding of and address potential barriers at the individual, community, and health facility levels through formative research with HIV-positive pregnant and postpartum women, their male partners, and health care providers. This information will be used to refine two proposed interventions that are highly likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants. These interventions will be rigorously tested in rural Kenya, using a cluster randomized 2x2 factorial design. The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory based mobile phone text messages to help retain women and infants in HIV care. The investigators' overall goal is to determine which intervention (or combination of interventions) maximizes ART adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes. The investigators' primary outcomes will include ART adherence at 12 months postpartum and retention in care, measured by a documented HIV care visit within 90 days prior to 12 months postpartum. Secondary outcomes will include MTCT at 6 weeks, 12 months and 18 months; as well as maternal viral loads and CD4 counts. Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions and combinations of interventions that can reduce barriers and increase facilitators of optimal ART adherence and retention in care with the aims of reaching the elimination of mother to child transmission of HIV and significantly improving maternal health.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older,
* HIV-infected pregnant women and their HIV-exposed infants pairs,
* attends the antenatal care (ANC) clinic at one of the study sites.

Exclusion Criteria:

* Less than 18 years of age,
* HIV-infected women not currently pregnant,
* not HIV-infected at the time of the first ANC visit.

Primary outcomes:
measure: Self-reported adherence on antiretroviral therapy
timeFrame: 12 months post-partum
measure: Adherence on antiretroviral therapy
timeFrame: 12 months post-partum
measure: Adherence on antiretroviral therapy (infant)
timeFrame: 12 months post-partum
measure: Retention in care
timeFrame: 12 months post-partum
measure: Adherence on antiretroviral therapy (dried blood spots)
timeFrame: 12 months post-partum
Secondary outcomes:
measure: Maternal CD4 count change
timeFrame: 6 months after baseline
measure: Maternal viral load count change
timeFrame: 6 months after baseline
measure: Infant retention in care (feeding method)
timeFrame: 12 and 18 months
measure: Infant retention in care
timeFrame: 12 and 18 months
measure: Infant retention in care (survival status)
timeFrame: 12 and 18 months
measure: Uptake of intervention services (Number/types of text messages sent)
timeFrame: 3 years
measure: Uptake of intervention services (receipt of text messages)
timeFrame: 3 years
measure: Uptake of intervention services (home visits)
timeFrame: 3 years
measure: Uptake of intervention services (support groups attended)
timeFrame: 3 years
measure: Mother-to-Child-Transmission
timeFrame: 6 weeks, 9 months and 18 months
measure: Infant testing
timeFrame: 6 weeks, 9 months and 18 months
measure: Infant enrollment in care
timeFrame: 6 weeks
measure: Male partner involvement
timeFrame: 12 months post-partum
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of Colorado, Denver
name: Lisa Abuogi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abuogi LL, Onono M, Odeny TA, Owuor K, Helova A, Hampanda K, Odwar T, Onyango D, McClure LA, Bukusi EA, Turan JM. 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). J Int AIDS Soc. 2022 Jan;25(1):e25852. doi: 10.1002/jia2.25852.
citation: Helova A, Onono M, Abuogi LL, Hampanda K, Owuor K, Odwar T, Krishna S, Odhiambo G, Odeny T, Turan JM. Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study. J Int AIDS Soc. 2021 Nov;24(11):e25843. doi: 10.1002/jia2.25843.
citation: Onono M, Odwar T, Wahome S, Helova A, Bukusi EA, Hampanda K, Turan J, Abuogi L. Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):46-55. doi: 10.1097/QAI.0000000000002521.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Wanga I, Helova A, Abuogi LL, Bukusi EA, Nalwa W, Akama E, Odeny TA, Turan JM, Onono M. Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):288. doi: 10.1186/s12884-019-2419-z.
citation: Odeny TA, Onono M, Owuor K, Helova A, Wanga I, Bukusi EA, Turan JM, Abuogi LL. Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial. Trials. 2018 Jan 29;19(1):77. doi: 10.1186/s13063-018-2464-3.