Clinical trial NCT01191203: Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Official title: Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Acceptability and Adherence to methods
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-08-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The IUD is an extremely effective method of contraception yet few women use it worldwide. Considered safe to use in HIV+ women, few studies have evaluated its use among those using antiretroviral therapy. The only prior randomized trial looking at the IUD compared to hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD acceptability and continuation is critical to improve utilization.

* Objective 1: Determine WHO medical eligibility and the willingness for IUD placement
* Objective 2: Compare method-related side effects and adverse events
* Objective 3: Assess the 1-year acceptability and continuation rates

Methods: To address our objectives the investigators have designed a two Phase Study:

* A cross-sectional screening to evaluate contraceptive medical eligibility and desirability
* A randomized controlled trial that will compare acceptability and adherence to DMPA compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to follow for 1 year


Eligibility criteria: Inclusion Criteria:

* Can provide informed consent
* Women ages 18-45
* Known HIV + status on antiretroviral therapy for at least 6 months
* Not currently pregnant
* Willing to initiate either DMPA or CuT380A-IUD. Women currently using DMPA or CuT380A-IUD will be excluded
* Do not desire to become pregnant within next 12 months
* Intend to stay in Lilongwe region for the duration of the study
* No known uterine anomalies based upon history
* Greater than or equal to 4 weeks post partum
* No known or suspected genital tract cancer
* No evidence of current pelvic inflammatory disease or cervicitis. Women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment
* No pelvic inflammatory disease within prior 3 months
* No contraindications to DMPA or the CuT380A-IUD per the WHO medical eligibility criteria or Malawi National Reproductive Health Service Delivery Guidelines, 2007
* Based on clinical assessment, no condition that would preclude start of study intervention

Exclusion Criteria:

* Women ages younger than18 or older than 45
* Known HIV + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy
* Pregnant
* Uterine anomaly
* Less than 4 weeks post partum
* Suspected genital tract cancer

Inclusion Criteria:

•Current STI or PID

Primary outcomes:
measure: Adherence
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: The Lighthouse Trust
Study officials:
affiliation: Emory University
name: Lisa Haddad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lighthouse Trust
name: Sam Phiri, PhD
role: PRINCIPAL_INVESTIGATOR
References: