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

13 de outubro de 2022 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

232

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Malauí
      • Blantyre, Malauí
        • Blantyre Clinical Research Site
  • Uganda
      • Kampala, Uganda
        • Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
  • Zimbábue
      • Harare, Zimbábue
        • Zengeza Clinical Research Site
  • África do Sul
      • Johannesburg, África do Sul
        • Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comportamental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use
Prazo: 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
Prazo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Product preferences during pregnancy and breastfeeding
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 3-6 months during Q2/Q3 2018
Focus group discussions and key informant in-depth interviews
3-6 months during Q2/Q3 2018

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Microbicide Trials Network

Colaboradores

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)

Investigadores

  • Cadeira de estudo: Ariane van der Straten, PhD, MPH, Women's Global Health Imperative Program, RTI International

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de maio de 2018

Conclusão Primária (Real)

2 de novembro de 2018

Conclusão do estudo (Real)

2 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

2 de agosto de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de agosto de 2018

Primeira postagem (Real)

28 de agosto de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de outubro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de outubro de 2022

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • MTN-041
  • UM1AI068633 (Concessão/Contrato do NIH dos EUA)
  • UM1AI068615 (Concessão/Contrato do NIH dos EUA)
  • UM1AI106707 (Concessão/Contrato do NIH dos EUA)
  • 38161 (Outro identificador: DAIDS)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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