- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02491177
Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE!)
22. april 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
1338
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Nairobi, Kenya
- Kenya Medical Research Institute
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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
|
Annen: 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
|
Annen: 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 inngripen: Neither cMM nor Text Messaging
Participants randomized to this arm will receive standard of care with no interventions.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
6 months after baseline
|
Infant retention in care (feeding method)
Tidsramme: 12 and 18 months
|
Infant feeding method
|
12 and 18 months
|
Infant retention in care
Tidsramme: 12 and 18 months
|
Retention in care through 12 and 18 months
|
12 and 18 months
|
Infant retention in care (survival status)
Tidsramme: 12 and 18 months
|
Survival status of infant
|
12 and 18 months
|
Uptake of intervention services (Number/types of text messages sent)
Tidsramme: 3 years
|
Number/types of text messages sent
|
3 years
|
Uptake of intervention services (receipt of text messages)
Tidsramme: 3 years
|
Receipt of text messages
|
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
|
Number of support groups attended.
|
3 years
|
Mother-to-Child-Transmission
Tidsramme: 6 weeks, 9 months and 18 months
|
Result of infant HIV test at 6 wks, 9,18 months
|
6 weeks, 9 months and 18 months
|
Infant testing
Tidsramme: 6 weeks, 9 months and 18 months
|
Uptake and date of infant testing
|
6 weeks, 9 months and 18 months
|
Infant enrollment in care
Tidsramme: 6 weeks
|
Infant enrollment in HIV care
|
6 weeks
|
Male partner involvement
Tidsramme: 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.
|
12 months post-partum
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa Abuogi, MD, MSc, University of Colorado, Denver
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2014
Primær fullføring (Faktiske)
1. april 2019
Studiet fullført (Faktiske)
1. mars 2021
Datoer for studieregistrering
Først innsendt
11. mars 2015
Først innsendt som oppfylte QC-kriteriene
2. juli 2015
Først lagt ut (Anslag)
7. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Oppbevaring i omsorgen
- Spedbarnshelse
- Kobling til omsorg
- Vertikal overføring
- Tidlig spedbarnsdiagnose
- HIV-overføring
- Overholdelse av antiretroviral terapi
- Forebygging av overføring fra mor til barn
- Samfunnsmentor mødre
- Mobile phone text messaging
- Mors CD4/viral belastning
- Akseptabilitet av intervensjoner
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 14-0331
- R01HD080477-01 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Humant immunsviktvirus
-
Columbia UniversityNational Institute of Mental Health (NIMH); Ministry of Health and Social...FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Tanzania
-
University of California, BerkeleyHealth for a Prosperous Nation; Tanzania Ministry of Health, Community... og andre samarbeidspartnereAktiv, ikke rekrutterendeHIV (Human Immunodeficiency Virus)Tanzania
-
Columbia UniversityFullførtHIV (Human Immunodeficiency Virus)Forente stater
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereAktiv, ikke rekrutterende
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID); New York... og andre samarbeidspartnereFullførtHIV (Human Immunodeficiency Virus)Swaziland
-
Columbia UniversityNational Institute of Nursing Research (NINR)FullførtHIV (Human Immunodeficiency Virus) | AIDS (ervervet immunsviktsyndrom)Forente stater
-
Columbia UniversityMinistry of Health, SwazilandFullført
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health, Tanzania; Management and Development for Health og andre samarbeidspartnereRekruttering
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)FullførtSeksuelt overførbare sykdommer | HIV (Human Immunodeficiency Virus)Forente stater
-
University of California, Los AngelesAvsluttetHepatitt C | HIV (Human Immunodeficiency Virus)Forente stater
Kliniske studier på cMM
-
NeuraLace Medical, Inc.Aktiv, ikke rekrutterendeNevralgi | Nevropatisk smerte | Smertefull diabetisk nevropatiForente stater
-
NeuraLace Medical, Inc.Aktiv, ikke rekrutterendeNevropatisk smerte | Perifer nevropatiForente stater
-
Nevro CorpAktiv, ikke rekrutterende
-
Nevro CorpAktiv, ikke rekrutterendeSmertefull diabetisk nevropatiForente stater
-
Aurora Health CareRekrutteringSmertefull diabetisk nevropatiForente stater
-
Vertos Medical, Inc.Aktiv, ikke rekrutterendeSpinal stenose, lumbal region, med nevrogen ClaudicationForente stater
-
Nevro CorpRekrutteringSmertefull diabetisk nevropatiForente stater
-
University of MinnesotaMedica FoundationFullførtHypertensjon | Diabetes | Høyt kolesterolForente stater