The WHICH injection study (Part 1)

Not Applicable

Recruiting

• Conditions: Mental and Behavioural Disorders

• Registration Number: PACTR202009758229976
• Lead Sponsor: niversity of Fort Hare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 520

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary hormonal outcome will be serum 17ß estradiol, and the primary psychological outcome will be depression (BDI-II).

Secondary Outcome Measures

Name	Time	Method
Sentinal immune suppression markers (eg CCR5 levels on T cells and CD14+ cells from genital tract samples; plasma interferon?).<br>Serum sex hormone binding globulin<br>Serum testosterone<br>Serum free testosterone<br>Serum progesterone<br>Additional depression measures<br>Sexual dysfunction<br>Sexual activity including condom use<br>Amenorrhoea<br>Weight change<br>Adherence<br>