NCT02491177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

4.9 years

First QC Date

March 11, 2015

Last Update Submit

April 22, 2021

Conditions

Human Immunodeficiency Virus

Keywords

HIV TransmissionPrevention of Mother to Child TransmissionLinkage to careRetention in careCommunity Mentor MothersMobile phone text messagingAntiretroviral therapy adherenceInfant HealthMaternal CD4/viral loadsEarly infant diagnosisAcceptability of interventionsVertical transmission

Outcome Measures

Primary Outcomes (5)

  • Self-reported adherence on antiretroviral therapy

    Self-report

    12 months post-partum

  • Adherence on antiretroviral therapy

    Viral load\<100 copies/ml based on medical records

    12 months post-partum

  • Adherence on antiretroviral therapy (infant)

    Use of ARVs for the infant

    12 months post-partum

  • 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

  • Adherence on antiretroviral therapy (dried blood spots)

    Viral load\<100 copies/ml based on dried blood spots

    12 months post-partum

Secondary Outcomes (13)

  • Maternal CD4 count change

    6 months after baseline

  • Maternal viral load count change

    6 months after baseline

  • Infant retention in care (feeding method)

    12 and 18 months

  • Infant retention in care

    12 and 18 months

  • Infant retention in care (survival status)

    12 and 18 months

  • +8 more secondary outcomes

Study Arms (4)

cMM and Text Messaging

OTHER

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: cMMBehavioral: Text Messaging

cMM Only

OTHER

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

Text Messaging Only

OTHER

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

Neither cMM nor Text Messaging

NO INTERVENTION

Participants randomized to this arm will receive standard of care with no interventions.

Interventions

cMMBEHAVIORAL

Home visits from community mentor mothers

cMM OnlycMM and Text Messaging
Text MessagingBEHAVIORAL

Text messages received on mobile phone

Text Messaging OnlycMM and Text Messaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

Related Publications (6)

  • 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.

    PMID: 35041776DERIVED

  • 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.

    PMID: 34797955DERIVED

  • 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.

    PMID: 33306563DERIVED

  • 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.

    PMID: 32813276DERIVED

  • 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.

    PMID: 31409297DERIVED

  • 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.

    PMID: 29378622DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Lisa Abuogi, MD, MSc

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

July 7, 2015

Study Start

May 1, 2014

Primary Completion

April 1, 2019

Study Completion

March 1, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

KE(1)