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Clinical Trials/PACTR202009758229976
PACTR202009758229976
Recruiting
未知

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 sites520 target enrollmentApril 15, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Mental and Behavioural Disorders
Sponsor
niversity of Fort Hare
Enrollment
520
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
niversity of Fort Hare

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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