The Women’s Health, Injectable Contraception and HIV study (Part 1): randomized comparison of immunological, hormonal, physiological, psychological and behavioural effects of NET-EN versus DMPA contraception.

niversity of Fort Hare0 个研究点目标入组 520 人开始时间: 2019年4月15日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Requests injectable contraception and intends to continue contraception for at least 18 months.
•Aged 18 to 40 years. Legally competent to sign consent according to local regulations..
•Prepared to use either NET-EN or DMPA
•Prepared to accept follow-up procedures and able to fulfil these procedures, including routine HIV tests according to national guidelines (see below).
•After full counselling, decline to use PrEP
•Understands patient information form and signs informed consent.

•Received DMPA in previous 6 months or NET-EN in previous 4 months
•HIV positive
•Planning to move out of study area in next 18 months
•Participating in another clinical trial
•<6 weeks postpartum or post-abortion
•Have Diabetes or High blood pressure
•Does not meet MEC criteria or local national guidelines for NET-EN or DMPA use.
•Using or intending to use medication which may interfere with biological measurements, for example steroids or drugs affecting renal function such as PrEP. Prospective participants will be fully informed about PrEP, and if interested in using PrEP, will be referred to any available local providers.Participants who, after recruitment, change their minds and decide to access PrEP services, will be kept in the study.

发起方

niversity of Fort Hare