HIVNCT01191203
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
A study testing Copper IUD and Depo Medroxyprogesterone acetate in people with HIV, run by Emory University at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- Copper IUD and Depo Medroxyprogesterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalawi
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
- •Current STI or PID
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
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
- Conditions
- HIV
- Being tested
- Copper IUD, Depo Medroxyprogesterone acetate
- Keywords
- Acceptability and Adherence to methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper IUDDrug
Copper IUD (CuT360)
Depo Medroxyprogesterone acetateDrug
Also called DMPA, Depo Provera
DMPA 150 mg IM q 3 months
| Study group | Role | What they receive |
|---|---|---|
| Depo Medroxyprogesterone Acetate | Active comparator | Not described Receives: Drug: Depo Medroxyprogesterone acetate |
| Copper IUD (CuT360) | Active comparator | Not described Receives: Drug: Copper IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of clients continuing with method at 1 year
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Lisa Haddad, Emory University
- Investigators
- Lisa Haddad, MD, Principal investigator, Emory UniversitySam Phiri, PhD, Principal investigator, Lighthouse Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191203
- Sponsor's protocol ID
- IRB00037535
- Status last verified
- Oct 2013
- First submitted
- 2 Jun 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01191203
- Acronym / sponsor ID
- IRB00037535
- Conditions
- HIV
- Keywords
- Acceptability and Adherence to methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depo Medroxyprogesterone Acetate | Active comparator | Drug: Depo Medroxyprogesterone acetate |
| Copper IUD (CuT360) | Active comparator | Drug: Copper IUD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper IUDCopper IUD (CuT360) | Drug | Copper IUD (CuT360) |
| Depo Medroxyprogesterone acetateAlso: DMPA, Depo ProveraDMPA 150 mg IM q 3 months | Drug | Depo Medroxyprogesterone Acetate |
Primary outcome
Adherence
Time frame: 1 year
Number of clients continuing with method at 1 year
1 secondary outcome
Adverse Events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Haddad, MD principal investigator
Emory University
Sam Phiri, PhD principal investigator
Lighthouse Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper IUD and Depo Medroxyprogesterone acetate in people with HIV, run by Emory University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.