Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: Copper IUD
* Drug: Depo Medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Depo Medroxyprogesterone Acetate<br> | Drug: Depo Medroxyprogesterone acetate<br>* DMPA 150 mg IM q 3 months<br>* Other names: Depo Provera;|
| Active Comparator: Copper IUD (CuT360)<br> | Drug: Copper IUD<br>* Copper IUD (CuT360)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of clients continuing with method at 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | -Number of clients who experience adverse events such as pelvic inflammatory disease, lower genital tract infection, and infection related complications, such as abdominal pain, and irregular vaginal bleeding, as well as lower tract infection determined by clinical examination. Side effects such as abnormal vaginal discharge, abnormal bleeding, IUCD expulsion, and other side effects, as measured by clinical examination and client self-report. -Risk of excessive vaginal bleeding or anemia: determined by self report and hemoglobin level | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptability and Adherence to methods