HIV/AIDS Fertility-female
Conditions
Interventions
Sponsors
FHI360
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ¿Change in detection and quantity of HIV RNA genital VL measures between study arms | — |
Secondary
| Measure | Time frame |
|---|---|
| ¿ Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change ;Hemoglobin change and incidence of STIs and PID for all participants through 24 months.;IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. ;¿ Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines). | — |
Countries
South Africa
Contacts
Public ContactAgnes Ronan
Project Manager
Outcome results
None listed