Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201503001050399 Date of Registration: 01/03/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Two IUDs among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Official scientific title Comparison of Two IUDs among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
Brief summary describing the background and objectives of the trial Family planning and preventing mother to child transmission (PMTCT) of Human Immunodeficiency Virus (HIV) through effective contraception are increasingly important. Analyses assessing various approaches to reducing mother to child HIV transmission conclude that preventing unplanned pregnancy is the most cost-effective PMTCT approach, spurring recommendations to integrate HIV care and reproductive health services. However, some studies have called into question the safety of systemic hormonal contraceptives for HIV-positive women and their partners. Studies have shown that the LNG IUD is an excellent method for many women and confers additional advantages to reliable contraception to HIV-positive women by reducing menstrual blood loss and medical visits compared to other hormonal methods. While the C-IUD is available in the public sector of South Africa and many sub-Saharan African countries and considered safe with respect to HIV progression, it is not widely offered or used The rationale for this study is the need for high-quality clinical evidence to determine whether the LNG IUD is safe for HIV-positive women with regard to HIV potential transmission to male partners and disease progression. The lack of evidence to suggest that adverse progestin-mediated effects might be associated with the LNG IUD, coupled with impending LNG IUD affordability, indicate that now is the time to establish LNG IUD safety and acceptability for HIV-positive women. Thus, this randomized control trial is needed to document safety and acceptability of the candidate method (LNG IUD) compared to a non-hormonal method with documented safety with regard to HIV transmission and progression (C-IUD).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 2IUDnCT
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 28/10/2013
Actual trial start date 28/10/2013
Anticipated date of last follow up 30/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 288
Actual target sample size (number of participants) 288
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FHI 360 Study 10369 FHI360
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Block randomization of randomly selected permuted blocks of 4 or 6 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mirena IUD Mirena IUD inserted at enrolment throughout study period Participant received Mirena IUD as their method of birth control 144
Experimental Group Levonorgestrel intrauterine device Mirena IUD inserted at enrolment throughout study period Participant received Mirena IUD as their method of birth control 144
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2013 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/11/2012 Protection of Human Subjects Committee
Ethics Committee Address
Street address City Postal code Country
2 2 4 E N C H w y 5 4 Durham N C 2 7 7 1 3 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Change in detection and quantity of HIV RNA genital VL measures between study arms Baseline 6 months Over 24 months
Secondary Outcome ¿ Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change Baseline 6 months 12 months 18 months 24 months
Secondary Outcome Hemoglobin change and incidence of STIs and PID for all participants through 24 months. Baseline 6 months 12 months 18 months 24 months
Secondary Outcome IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. From baseline through to the end of follow-up
Secondary Outcome ¿ Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines). Baseline 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gugulethu Community Health Centre Cnr NY77 and NY3 Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 6100 Executive Boulevard Rockville MD 20852 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FHI360 2 2 4 E N C H w y 5 4 Durham NC 27703 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Benjamin Landon Myer Faculty of Health Sciences, University of Cape Town Cape Town South Africa
Catherine Todd fhi360 Durham NC 27703 United States of America
Linda-Gail Bekker Desmond Tutu HIV Foundation Cape Town South Africa
Heidi Jones Hunter College, New York New York United States of America
Donald Hoover Indicium Data Insight, LLC Bluebell United States of America
Jo-Ann Passmore University of Cape Town Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Landon Myer landon.myer@uct.ac.za +27216506661 Faculty of Health Sciences, Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Agnes Ronan agnes.ronan@uct.ac.za +27216506713 Faculty of Health Sciences, Anzio Road
City Postal code Country Position/Affiliation
Cape Town South Africa Project Manager
Role Name Email Phone Street address
Scientific Enquiries Catherine Todd CTodd@fhi360.org +66 (0) 849790115 Asia-Pacific Region & Clinical Sciences Division
City Postal code Country Position/Affiliation
Bangkok Thailand Medical Monitor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information