- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02216734
Effects of Facility-based Mother Support Groups on Prevention of mother-to Child Transmission Outcomes in Zimbabwe (EPAZ)
Effects of Mother Support Groups on Prevention of Mother-To-Child Transmission (PMTCT) Outcomes in Mutare & Makoni Districts, Zimbabwe: A Cluster Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVE To test whether MSGs lead to increased retention of HIV-exposed infants in PMTCT programmes
SECONDARY OBJECTIVES
- To assess whether MSGs lead to increased retention of mothers in postnatal HIV follow-up care
- To assess whether male participation in PMTCT activities is increased at clinics with MSGs
- To assess whether selected maternal and infant health indicators are improved in HIV-positive mothers and their exposed infants at facilities with MSGs, viz. (1) Antenatal attendance; (2) Delivery in facilities; (3) Infant immunisation uptake; (4) Infant feeding methods and nutrition status; (5) Infant nevirapine prophylaxis; (6) Infant co-trimoxazole prophylaxis; (7) Infant HIV testing; and (8) Family planning uptake
MOTHER SUPPORT GROUP INTERVENTION MSGs were designed following formative research. A non-governmental organisation established MSGs by recruiting HIV+ mothers and volunteer coordinators (MSGCs) prior to commencing enrolment. MSGCs were HIV-positive mothers who were trained in MSG establishment and maintenance, retention activities and data collection. MSGs meet each two weeks with the MSGC or health worker facilitating an information session using a curriculum of eight PMTCT-related topics. MSGCs send standard message reminders to members, contact non-attending members by phone and inform health workers (HWs) to assist retention. HWs conduct retention actions of non-attending patients in PMTCT programmes.
SAMPLE SIZE AND RANDOMISATION We excluded from the study low-volume facilities that recorded booking fewer than 10 HIV-positive antenatal mothers per annum. We randomly selected facilities in the two study districts to either of the study arms. Based on estimated infant retention rates for control and intervention arms, we calculated the minimum sample size of 10 HIV-positive mothers to be enrolled at each health facility.
DATA COLLECTION, ANALYSIS AND QUALITY ASSURANCE The study utilizes the existing health information system (e.g. antenatal care (ANC) Register, Exposed Infant Follow-Up Register, Anti-retroviral treatment (ART) Register), supplemented by EPAZ study-related data collection and patient tracking systems. Study staff will work with clinic- and district-level staff to improve and collect routine and study-specific data. Data will be entered, coded, cleaned and locked before analyses are made. Data will be analysed on an intention-to-treat basis. A mobile team of well-trained quality assurance and control study staff will be deployed throughout the data collection period to ensure quality of the intervention and of data generated and collected at each study site. A pre-specified proportion of patient visit records will be reviewed from each site.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Geoff Foster, MB BS MRCP
- Numero di telefono: +263772265830
- Email: geofffoster53@gmail.com
Luoghi di studio
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Manicaland
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Mutare, Manicaland, Zimbabwe
- Reclutamento
- Family AIDS Caring Trust
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Contatto:
- Vhumani Magezi
- Numero di telefono: +2632061648
- Email: vhumani@hotmail.com
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Mutare, Manicaland, Zimbabwe
- Iscrizione su invito
- Family AIDS Caring Trust
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Pregnant mothers
- with documented HIV-1 infection attending an antenatal clinic for the current pregnancy
- Aged 18 years of age or greater
- Attending the clinic with no known intention at the time of enrolment to permanently migrate outside the catchment area of the clinic for the duration of the study follow-up period
- Estimated gestational age of 34 weeks or less at time of enrolment
- Willing to have her infant, when born, participate in the study.
- Able and willing to give informed consent to participate
Exclusion Criteria:
- Pregnant mothers with no documented HIV infection
- Under 18 years of age
- Not able or willing to give informed consent to participate
- Estimated gestational age of over 34 weeks when considered for possible enrolment
- Not residing in catchment area of clinic
- Planning to relocate out of the catchment area of the clinic for the duration of study follow-up period or longer
- Any condition that in the opinion of the investigators would interfere with adherence to study requirements. Such conditions include mental illness or active drug or alcohol use or dependence.
- Unwilling for her infant, when born, to participate in the infant component of the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Mother support groups for HIV+ mothers
Facility-based mother support groups (MSGs) for HIV+ mothers.
MSGs were established prior to study enrolment.
MSGs are facilitated by volunteer mothers.
Groups meet every two weeks.
Health information is provided by health workers during MSGs.
Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment.
Mothers leave MSGs 6 months postnatally.
Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
|
Facility-based mother support groups (MSGs) for HIV+ mothers.
MSGs were established prior to study enrolment.
MSGs are facilitated by volunteer mothers.
Groups meet every two weeks.
Health information is provided by health workers during MSGs.
Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment.
Mothers leave MSGs 6 months postnatally.
Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
|
Nessun intervento: Standard of Care Arm
Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers.
LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
One-year retention rates of HIV-exposed infants in post-natal follow-up
Lasso di tempo: 12 months postnatal
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12 months postnatal
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
a. Retention rates of HIV-infected mothers
Lasso di tempo: 12 months postnatal
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12 months postnatal
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Geoff Foster, MB BS MRCP, Ministry of Health and Child Welfare, Zimbabwe
Pubblicazioni e link utili
Pubblicazioni generali
- Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.
- Foster G, Orne-Gliemann J, Font H, Kangwende A, Magezi V, Sengai T, Rusakaniko S, Shumba B, Zambezi P, Maphosa T. Impact of Facility-Based Mother Support Groups on Retention in Care and PMTCT Outcomes in Rural Zimbabwe: The EPAZ Cluster-Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S207-S215. doi: 10.1097/QAI.0000000000001360.
- Foster G, Kangwende A, Magezi V, Maphosa T, Mashapa R, Mukora-Mutseyekwa F, Mushavi A, Rusakaniko S, Shumba B, Zambezi P. Cluster randomized trial on the effect of mother support groups on retention-in-care and PMTCT outcomes in Zimbabwe: study design, challenges, and national relevance. J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S145-9. doi: 10.1097/QAI.0000000000000325.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Infezioni da HIV
Altri numeri di identificazione dello studio
- RPC526
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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