PACTR201503001050399Recruiting未知
Comparison of Two IUDs among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- FHI360
- Enrollment
- 288
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Year(s) to 40 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1. Willing, able to provide written informed consent (IC) to be screened for and participate in the trial
- •2. Interested and willing to use the IUD as a family planning method.
- •3. Between 18 - 40 years of age (inclusive): Age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.
- •4. Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:
- •a. Be randomized
- •b. Adhere to follow-up schedule; willing to be contacted by site staff between study visits (by phone and/or in person)
- •c. Provide contact/locator information
- •d. Agree for site staff to review clinic chart to confirm HIV status
- •5. Has documented HIV infection:
- •6. For pre-ART entrants:
- •a. ART-ineligible at screening, based on current South African ART guidelines
- •b. Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.
- •7. For ART-using entrants:
- •a. ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma VL<1000 copies/mL) at the most recent VL measure.
- •b. Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.
- •8. Intending residence in Cape Town area for next 30 mnths
- •9. No documented or known history of infertility or sterilization.
- •10. No gross evidence of cervical neoplasia on examination.
- •11. No prior history of ectopic pregnancy.
- •12. No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding.
- •13.Local language fluency and comprehension: Participants must speak one of languages commonly used in Cape Town populations of recruitment (English, isiXhosa) and must be able to comprehend the risks, benefits, and obligations of the study to provide IC, as determined through the informed consent comprehension checklist score.
- •14. Not participating in any other clinica
Exclusion Criteria
- •1. Documented or known history of infertility or sterilization.
- •2. Gross evidence of cervical neoplasia on examination.
- •3. Prior history of ectopic pregnancy.
- •4. History of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding.
- •5. Participating in any other clinical trial with a biomedical intervention.
Investigators
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