Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa (MAMMA)

13 ottobre 2022 aggiornato da: Microbicide Trials Network

Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding

The MTN-041 study is a multi-site exploratory study using focus group discussions (FGDs) and in-depth interviews (IDIs) to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly dapivirine (DPV) vaginal ring (VR) and daily oral pre-exposure prophylaxis (PrEP), by pregnant and breastfeeding women in Africa.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

MTN-041 is an exploratory study primarily designed to identify individual, interpersonal, social and cultural factors that may affect potential uptake of two safe and effective HIV prevention products, the monthly DPV VR and daily oral PrEP, in a vulnerable yet seldom-studied population, pregnant and breastfeeding women. MTN-041 will utilize FGDs and IDIs to elicit community and health professional perceptions about vaginal practices, sexual activity, use of medicines, and HIV risk during pregnancy or breastfeeding, including how these perceptions may affect pregnant and breastfeeding women's acceptability of using intravaginal products and oral medications like the DPV VR and Truvada oral tablet.

The MTN-041 study population will consist of HIV-uninfected women 18-40 years old who are currently or were recently (within two years) pregnant or breastfeeding, men aged 18 years or older whose partners are currently or were recently (within two years) pregnant or breastfeeding, grandmothers whose daughters or daughters-in-law are currently or were recently (within two years) pregnant or breastfeeding, and key informants (KIs), which include: health care professionals (HCPs), traditional birth attendants (TBAs), providers of family planning, antenatal, and traditional health services to women, providers of other social services to women, and community leaders.

Up to 60 men and women will be selected at each site for participation in this study, for a maximum total of 240 study participants. This includes up to 50 FGD participants (currently or recently pregnant or breastfeeding women, male partners of women who are currently or were recently pregnant or breastfeeding, and grandmothers with currently or recently pregnant or breastfeeding daughters/daughters-in-law) and up to 10 KIs selected at each site, for a maximum total of 200 FGD participants and 40 KIs enrolled across all sites.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

232

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Malawi
      • Blantyre, Malawi
        • Blantyre Clinical Research Site
  • Sud Africa
      • Johannesburg, Sud Africa
        • Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site
  • Uganda
      • Kampala, Uganda
        • Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
  • Zimbabwe
      • Harare, Zimbabwe
        • Zengeza Clinical Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The MTN-041 study population will consist of HIV-uninfected women 18-40 years old who are currently or were recently (within two years) pregnant or breastfeeding, men aged 18 years or older whose partners are currently or were recently (within two years) pregnant or breastfeeding, grandmothers whose daughters or daughters-in-law are currently or were recently (within two years) pregnant or breastfeeding, and key informants (KIs), which include: health care providers (HCPs), traditional birth attendants (TBAs), providers of family planning, antenatal, and traditional health services to women, providers of other social services to women, and community leaders.

Descrizione

Inclusion Criteria:

  1. Able and willing to provide written informed consent in one of the study languages.

  2. Able and willing to complete the required study procedures.

    For currently or recently pregnant or breastfeeding women:

  3. Between the ages of 18 to 40 years old (inclusive) at Enrolment, verified per site standard operating procedures (SOPs).

  4. Currently or recently (within two years) pregnant or breastfeeding (by self-report).

    For male partners:

  5. Aged 18 years or older at Enrolment, verified per site SOPs.

  6. Identifies as a primary sexual partner of a woman who is currently or was recently (within two years) pregnant or breastfeeding.

    For grandmothers:

  7. Aged 18 years or older at Enrolment, verified per site SOPs.

  8. Identifies as the maternal or paternal grandmother of a daughter or daughter-in-law who is currently or was recently (within two years) pregnant or breastfeeding.

    Note: The term "daughter-in-law" includes women who are/were not married to their male partner during or after pregnancy.

    For service provider KIs:

  9. Aged 18 years or older at Enrolment, verified per site SOPs.
  10. Currently working as a clinician (e.g., obstetrician, nurse, pharmacist, etc.), traditional care provider (e.g., TBA, healer, midwife, etc.), social service provider (e.g., social worker, family planning counselor, etc.) or community health worker in one of the study countries, verified per site SOPs.

  11. Experienced in providing services to pregnant and/or breastfeeding women.

    For community leader KIs:

  12. Aged 18 years or older at Enrolment, verified per site SOPs.
  13. Currently acting in a community leadership role (e.g., local chief, religious leader, etc.).

Exclusion Criteria:

  1. Has any condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  2. For currently or recently pregnant or breastfeeding women: known HIV-positive status, verified per recent health record (e.g., health passport, ante-natal book, HIV test card, or similar document) or by self-report if health record(s) not available.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Pregnant or Breastfeeding Women
No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.
Comportamentale: Focus Group Discussion (FGD)

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on:

  • Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
  • Perceptions of HIV risk during pregnancy and breastfeeding
  • Perceived role of male partners during pregnancy and breastfeeding
  • Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
  • Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
  • Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding
Male Partners
No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.
Comportamentale: Focus Group Discussion (FGD)

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on:

  • Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
  • Perceptions of HIV risk during pregnancy and breastfeeding
  • Perceived role of male partners during pregnancy and breastfeeding
  • Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
  • Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
  • Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding
Grandmothers
No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures.
Comportamentale: Focus Group Discussion (FGD)

No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on:

  • Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
  • Perceptions of HIV risk during pregnancy and breastfeeding
  • Perceived role of male partners during pregnancy and breastfeeding
  • Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
  • Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
  • Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding
Key Informants
No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures.
Comportamentale: In-depth Interview (IDI)

No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures, focusing on the following topics:

  • Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
  • Perceptions of HIV risk during pregnancy and breastfeeding
  • Perceived role of male partners during pregnancy and breastfeeding
  • Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
  • Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
  • How others in their professional and social networks and communities would view the VR and/or oral PrEP use by pregnant and breastfeeding women

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018
Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Product preferences during pregnancy and breastfeeding
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018
Sexual activity and contraceptive use during pregnancy and breastfeeding
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018
Perceptions of HIV risk during pregnancy and breastfeeding
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018
Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products
Lasso di tempo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Microbicide Trials Network

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigatori

  • Cattedra di studio: Ariane van der Straten, PhD, MPH, Women's Global Health Imperative Program, RTI International

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 maggio 2018

Completamento primario (Effettivo)

2 novembre 2018

Completamento dello studio (Effettivo)

2 novembre 2018

Date di iscrizione allo studio

Primo inviato

2 agosto 2018

Primo inviato che soddisfa i criteri di controllo qualità

23 agosto 2018

Primo Inserito (Effettivo)

28 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2022

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • MTN-041
  • UM1AI068633 (Sovvenzione/contratto NIH degli Stati Uniti)
  • UM1AI068615 (Sovvenzione/contratto NIH degli Stati Uniti)
  • UM1AI106707 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 38161 (Altro identificatore: DAIDS)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

Prove cliniche su Prevenzione dell'HIV

Prove cliniche su Focus Group Discussion (FGD)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Benin

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi