Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa (MAMMA)
Qualitative Assessment of Acceptability of Vaginal Ring (VR) and Oral Pre-exposure Prophylaxis (PrEP) Use During Pregnancy and Breastfeeding
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Harare, Зимбабве
- Zengeza Clinical Research Site
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Blantyre, Малави
- Blantyre Clinical Research Site
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Kampala, Уганда
- Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration Clinical Research Site
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Johannesburg, Южная Африка
- Wits Reproductive Health and HIV Institute (WRHI) Clinical Research Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Able and willing to provide written informed consent in one of the study languages.
Able and willing to complete the required study procedures.
For currently or recently pregnant or breastfeeding women:
- Between the ages of 18 to 40 years old (inclusive) at Enrolment, verified per site standard operating procedures (SOPs).
Currently or recently (within two years) pregnant or breastfeeding (by self-report).
For male partners:
- Aged 18 years or older at Enrolment, verified per site SOPs.
Identifies as a primary sexual partner of a woman who is currently or was recently (within two years) pregnant or breastfeeding.
For grandmothers:
- Aged 18 years or older at Enrolment, verified per site SOPs.
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:
- Aged 18 years or older at Enrolment, verified per site SOPs.
- 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.
Experienced in providing services to pregnant and/or breastfeeding women.
For community leader KIs:
- Aged 18 years or older at Enrolment, verified per site SOPs.
- Currently acting in a community leadership role (e.g., local chief, religious leader, etc.).
Exclusion Criteria:
- 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.
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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.
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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:
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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.
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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:
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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.
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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:
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Key Informants
No actual intervention is planned.
A single in-depth interview (IDI) will be conducted to assess study outcome measures.
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No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures, focusing on the following topics:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Acceptability of VR during pregnancy and breastfeeding, including willingness to use the VR or support its use
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Acceptability of oral PrEP during pregnancy and breastfeeding, including willingness to use oral PrEP or support its use
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Product preferences during pregnancy and breastfeeding
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Sexual activity and contraceptive use during pregnancy and breastfeeding
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Perceptions of HIV risk during pregnancy and breastfeeding
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Community beliefs and practices related to pregnancy and breastfeeding, including use of oral medications and intravaginal products
Временное ограничение: 3-6 months during Q2/Q3 2018
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Focus group discussions and key informant in-depth interviews
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3-6 months during Q2/Q3 2018
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Учебный стул: Ariane van der Straten, PhD, MPH, Women's Global Health Imperative Program, RTI International
Публикации и полезные ссылки
Общие публикации
- van der Straten A, Ryan JH, Reddy K, Etima J, Taulo F, Mutero P, Taylor J, Piper J, Musara P; MTN-041/MAMMA Study Team. Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study. J Int AIDS Soc. 2020 Jun;23(6):e25536. doi: 10.1002/jia2.25536.
- Flax VL, Hawley I, Ryan J, Chitukuta M, Mathebula F, Nakalega R, Seyama L, Taulo F, van der Straten A; MTN-041/MAMMA Study Team. After their wives have delivered, a lot of men like going out: Perceptions of HIV transmission risk and support for HIV prevention methods during breastfeeding in sub-Saharan Africa. Matern Child Nutr. 2021 Apr;17(2):e13120. doi: 10.1111/mcn.13120. Epub 2020 Dec 15.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- MTN-041
- UM1AI068633 (Грант/контракт NIH США)
- UM1AI068615 (Грант/контракт NIH США)
- UM1AI106707 (Грант/контракт NIH США)
- 38161 (Другой идентификатор: DAIDS)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .