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Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02491177
Recruitment Status : Active, not recruiting
First Posted : July 7, 2015
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
University of Alabama at Birmingham
Kenya Medical Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: cMM Behavioral: Text Messaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1338 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Actual Study Start Date : May 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
cMM and 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.
Behavioral: cMM
Home visits from community mentor mothers

Behavioral: Text Messaging
Text messages received on mobile phone

cMM Only
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.
Behavioral: cMM
Home visits from community mentor mothers

Text Messaging Only
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.
Behavioral: Text Messaging
Text messages received on mobile phone

No Intervention: Neither cMM nor Text Messaging
Participants randomized to this arm will receive standard of care with no interventions.



Primary Outcome Measures :
  1. Self-reported adherence on antiretroviral therapy [ Time Frame: 12 months post-partum ]
    Self-report

  2. Adherence on antiretroviral therapy [ Time Frame: 12 months post-partum ]
    Viral load<100 copies/ml based on medical records

  3. Adherence on antiretroviral therapy (infant) [ Time Frame: 12 months post-partum ]
    Use of ARVs for the infant

  4. Retention in care [ Time Frame: 12 months post-partum ]
    Proportion of women who have an HIV care visit within 90 days at 12 months after the birth

  5. Adherence on antiretroviral therapy (dried blood spots) [ Time Frame: 12 months post-partum ]
    Viral load<100 copies/ml based on dried blood spots


Secondary Outcome Measures :
  1. Maternal CD4 count change [ Time Frame: 6 months after baseline ]
    Change in CD4 count baseline to 6 months after baseline

  2. Maternal viral load count change [ Time Frame: 6 months after baseline ]
    Change in viral load from baseline to 6 months after baseline

  3. Infant retention in care (feeding method) [ Time Frame: 12 and 18 months ]
    Infant feeding method

  4. Infant retention in care [ Time Frame: 12 and 18 months ]
    Retention in care through 12 and 18 months

  5. Infant retention in care (survival status) [ Time Frame: 12 and 18 months ]
    Survival status of infant

  6. Uptake of intervention services (Number/types of text messages sent) [ Time Frame: 3 years ]
    Number/types of text messages sent

  7. Uptake of intervention services (receipt of text messages) [ Time Frame: 3 years ]
    Receipt of text messages

  8. Uptake of intervention services (home visits) [ Time Frame: 3 years ]
    Number of home visits received

  9. Uptake of intervention services (support groups attended) [ Time Frame: 3 years ]
    Number of support groups attended.

  10. Mother-to-Child-Transmission [ Time Frame: 6 weeks, 9 months and 18 months ]
    Result of infant HIV test at 6 wks, 9,18 months

  11. Infant testing [ Time Frame: 6 weeks, 9 months and 18 months ]
    Uptake and date of infant testing

  12. Infant enrollment in care [ Time Frame: 6 weeks ]
    Infant enrollment in HIV care

  13. Male partner involvement [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491177


Locations
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Kenya
Kenya Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
University of Colorado, Denver
University of Alabama at Birmingham
Kenya Medical Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Lisa Abuogi, MD, MSc University of Colorado, Denver

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02491177     History of Changes
Other Study ID Numbers: 14-0331
R01HD080477-01 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
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

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases