- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02491177
Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE!)
22. april 2021 opdateret af: University of Colorado, Denver
Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1338
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Nairobi, Kenya
- Kenya Medical Research Institute
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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.
|
Home visits from community mentor mothers
Text messages received on mobile phone
|
Andet: 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.
|
Home visits from community mentor mothers
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Andet: 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.
|
Text messages received on mobile phone
|
Ingen indgriben: Neither cMM nor Text Messaging
Participants randomized to this arm will receive standard of care with no interventions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Self-reported adherence on antiretroviral therapy
Tidsramme: 12 months post-partum
|
Self-report
|
12 months post-partum
|
Adherence on antiretroviral therapy
Tidsramme: 12 months post-partum
|
Viral load<100 copies/ml based on medical records
|
12 months post-partum
|
Adherence on antiretroviral therapy (infant)
Tidsramme: 12 months post-partum
|
Use of ARVs for the infant
|
12 months post-partum
|
Retention in care
Tidsramme: 12 months post-partum
|
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)
Tidsramme: 12 months post-partum
|
Viral load<100 copies/ml based on dried blood spots
|
12 months post-partum
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maternal CD4 count change
Tidsramme: 6 months after baseline
|
Change in CD4 count baseline to 6 months after baseline
|
6 months after baseline
|
Maternal viral load count change
Tidsramme: 6 months after baseline
|
Change in viral load from baseline to 6 months after baseline
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6 months after baseline
|
Infant retention in care (feeding method)
Tidsramme: 12 and 18 months
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Infant feeding method
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12 and 18 months
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Infant retention in care
Tidsramme: 12 and 18 months
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Retention in care through 12 and 18 months
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12 and 18 months
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Infant retention in care (survival status)
Tidsramme: 12 and 18 months
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Survival status of infant
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12 and 18 months
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Uptake of intervention services (Number/types of text messages sent)
Tidsramme: 3 years
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Number/types of text messages sent
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3 years
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Uptake of intervention services (receipt of text messages)
Tidsramme: 3 years
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Receipt of text messages
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3 years
|
Uptake of intervention services (home visits)
Tidsramme: 3 years
|
Number of home visits received
|
3 years
|
Uptake of intervention services (support groups attended)
Tidsramme: 3 years
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Number of support groups attended.
|
3 years
|
Mother-to-Child-Transmission
Tidsramme: 6 weeks, 9 months and 18 months
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Result of infant HIV test at 6 wks, 9,18 months
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6 weeks, 9 months and 18 months
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Infant testing
Tidsramme: 6 weeks, 9 months and 18 months
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Uptake and date of infant testing
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6 weeks, 9 months and 18 months
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Infant enrollment in care
Tidsramme: 6 weeks
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Infant enrollment in HIV care
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6 weeks
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Male partner involvement
Tidsramme: 12 months post-partum
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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.
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12 months post-partum
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa Abuogi, MD, MSc, University of Colorado, Denver
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2014
Primær færdiggørelse (Faktiske)
1. april 2019
Studieafslutning (Faktiske)
1. marts 2021
Datoer for studieregistrering
Først indsendt
11. marts 2015
Først indsendt, der opfyldte QC-kriterier
2. juli 2015
Først opslået (Skøn)
7. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Fastholdelse i plejen
- Spædbørns sundhed
- Kobling til pleje
- Lodret transmission
- Tidlig spædbørnsdiagnose
- HIV-overførsel
- Adhærens af antiretroviral terapi
- Forebyggelse af overførsel fra mor til barn
- Community Mentor Mødre
- Mobile phone text messaging
- Maternal CD4/viral belastning
- Acceptabilitet af indgreb
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- 14-0331
- R01HD080477-01 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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