Mother and Infant Visit Adherence and Treatment Engagement Study
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: cMMBehavioral: Text Messaging
- Registration Number
- NCT02491177
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1338
- 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.
- Less than 18 years of age,
- HIV-infected women not currently pregnant,
- not HIV-infected at the time of the first ANC visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description cMM and Text Messaging cMM Participants randomized to this arm will receive both the community mentor mother and mobile phone text messaging intervention. The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. cMM and Text Messaging Text Messaging Participants randomized to this arm will receive both the community mentor mother and mobile phone text messaging intervention. The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. cMM Only cMM Participants randomized to this arm will receive the community mentor mother intervention only.The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. Text Messaging Only Text Messaging Participants randomized to this arm will receive the mobile phone text messaging intervention only. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language.
- Primary Outcome Measures
Name Time Method Self-reported adherence on antiretroviral therapy 12 months post-partum Self-report
Adherence on antiretroviral therapy (infant) 12 months post-partum Use of ARVs for the infant
Retention in care 12 months post-partum Proportion of women who have an HIV care visit within 90 days at 12 months after the birth
Adherence on antiretroviral therapy (dried blood spots) 12 months post-partum Viral load\<100 copies/ml based on dried blood spots
Adherence on antiretroviral therapy 12 months post-partum Viral load\<100 copies/ml based on medical records
- Secondary Outcome Measures
Name Time Method Infant enrollment in care 6 weeks Infant enrollment in HIV care
Infant retention in care (feeding method) 12 and 18 months Infant feeding method
Uptake of intervention services (receipt of text messages) 3 years Receipt of text messages
Maternal viral load count change 6 months after baseline Change in viral load from baseline to 6 months after baseline
Uptake of intervention services (Number/types of text messages sent) 3 years Number/types of text messages sent
Infant testing 6 weeks, 9 months and 18 months Uptake and date of infant testing
Infant retention in care 12 and 18 months Retention in care through 12 and 18 months
Infant retention in care (survival status) 12 and 18 months Survival status of infant
Uptake of intervention services (home visits) 3 years Number of home visits received
Mother-to-Child-Transmission 6 weeks, 9 months and 18 months Result of infant HIV test at 6 wks, 9,18 months
Maternal CD4 count change 6 months after baseline Change in CD4 count baseline to 6 months after baseline
Uptake of intervention services (support groups attended) 3 years Number of support groups attended.
Male partner involvement 12 months post-partum Composite variable including Y/N response to indicate if male partner attended a health visit with his female partner, encouraged facility delivery, reminded to take HIV medication, reminded to go for HIV care, provided transport money to go to the clinic/dispensary, reminded to give the infant prophylaxis, helped giving the infant prophylaxis medication, collected medication for the woman or infant, encouraged specific infant feeding, and encouraged pediatric HIV testing. These are assessed in the follow-up questionnaires completed at 12 months post-partum.
Trial Locations
- Locations (1)
Kenya Medical Research Institute
🇰🇪Nairobi, Kenya