Mother and Infant Visit Adherence and Treatment Engagement Study

Human Immunodeficiency Virus Clinical Trial

— MOTIVATE!  

Official title:

Maximizing Adherence and Retention for Women and Infants in the Context of Option B+

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491177
• Other study ID #: 14-0331
• Secondary ID: R01HD080477-01
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2021

Study information

• Verified date: April 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1338
• Est. completion date: March 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• cMM
Home visits from community mentor mothers
• Text Messaging
Text messages received on mobile phone

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Medical Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported adherence on antiretroviral therapy	Self-report	12 months post-partum
Primary	Adherence on antiretroviral therapy	Viral load<100 copies/ml based on medical records	12 months post-partum
Primary	Adherence on antiretroviral therapy (infant)	Use of ARVs for the infant	12 months post-partum
Primary	Retention in care	Proportion of women who have an HIV care visit within 90 days at 12 months after the birth	12 months post-partum
Primary	Adherence on antiretroviral therapy (dried blood spots)	Viral load<100 copies/ml based on dried blood spots	12 months post-partum
Secondary	Maternal CD4 count change	Change in CD4 count baseline to 6 months after baseline	6 months after baseline
Secondary	Maternal viral load count change	Change in viral load from baseline to 6 months after baseline	6 months after baseline
Secondary	Infant retention in care (feeding method)	Infant feeding method	12 and 18 months
Secondary	Infant retention in care	Retention in care through 12 and 18 months	12 and 18 months
Secondary	Infant retention in care (survival status)	Survival status of infant	12 and 18 months
Secondary	Uptake of intervention services (Number/types of text messages sent)	Number/types of text messages sent	3 years
Secondary	Uptake of intervention services (receipt of text messages)	Receipt of text messages	3 years
Secondary	Uptake of intervention services (home visits)	Number of home visits received	3 years
Secondary	Uptake of intervention services (support groups attended)	Number of support groups attended.	3 years
Secondary	Mother-to-Child-Transmission	Result of infant HIV test at 6 wks, 9,18 months	6 weeks, 9 months and 18 months
Secondary	Infant testing	Uptake and date of infant testing	6 weeks, 9 months and 18 months
Secondary	Infant enrollment in care	Infant enrollment in HIV care	6 weeks
Secondary	Male partner involvement	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.	12 months post-partum