Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women

HIV Clinical Trial

Official title:

Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721798
• Other study ID #: 10369
• Status: Completed
• Phase: N/A
• Start date: November 10, 2013
• Est. completion date: July 13, 2018

Study information

• Verified date: May 2023
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.

Description:

Design: Single site, double-blind, randomized controlled trial

Population: HIV-positive South African women between the ages of 18 and 40 years

Study size: At least 166 women

Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)

Duration & Follow-up: Approximately 48 months in total. Recruitment will take approximately 24 months. After enrollment, each participant will be followed for 24 months.

Primary Objectives: To compare LNG IUD safety to the safety of the C-IUD with respect to genital HIV shedding, a surrogate for potential for HIV transmission, overall and in the presence and absence of antiretroviral therapy (ART).

Secondary Objectives: 1) To compare LNG IUD safety to the safety of the C-IUD with respect to HIV progression as measured by changes in plasma viral load (VL) at 6 months between the two pre-ART study arms. 2) To explore LNG IUD safety with respect to non-HIV related outcomes, including hemoglobin change, incidence of sexually-transmitted infections (STIs) and pelvic inflammatory disease (PID). 3) To measure LNG IUD acceptability through device continuation and other measures for the LNG IUD as compared to the C-IUD. 4) To compare three genital tract sampling methods to determine which provides optimal recovery of HIV RNA and immune mediators over a series of three visits.

Primary Endpoints: Change in detection and quantity of HIV ribonucleic acid (RNA) genital VL measures between study arms at baseline and 6 months, and over 24 months following IUD insertion.

Secondary Endpoints: 1) Measures of HIV disease progression, including CD4 change, time to ART initiation, and mean plasma VL change from baseline to 6 and through 24 months among pre-ART women. 2) Hemoglobin change and incidence of STIs and PID for all participants through 24 months. 3) IUD continuation and expulsion rates between study arms comparing different IUDs over a 24-month period and acceptability measures through quantitative and qualitative methods. 4) Comparison of female genital tract sampling methods for recovery of HIV RNA as measured by VL and immune mediators (e.g. cytokines).

Study Site: Gugulethu Community Health Centre (GCHC), Cape Town, South Africa

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria

• Willing and able to provide written informed consent (IC) to be screened for and to participate in the trial

• Interested and willing to use the intrauterine device (IUD) as a family planning method.

• Between 18 to 40 years of age (inclusive): This age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.

• Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:

• Be randomized

• Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)

• Provide contact/locator information

• Agree for site staff to review clinic chart to confirm HIV status

• Has documented HIV infection

• For pre-antiretroviral therapy (ART) entrants:

• ART-ineligible at screening, based on current South African ART guidelines

• Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.

• For ART-using entrants:

• ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma viral load (VL)<1000 copies/mL) at the most recent VL measure.

• Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.

• Intending residence in Cape Town area for next 30 months

• No documented or known history of infertility or sterilization

• No gross evidence of cervical neoplasia on examination

• No prior history of ectopic pregnancy

• No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding

• Local language fluency and comprehension

• Not participating in any other clinical trial with a biomedical intervention

• Have no condition that, based on the opinion of the Site Principal Investigator (PI), would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.

Exclusion Criteria:

• Known congenital or acquired uterine anomaly including fibroids distorting the uterine cavity;

• Known acute liver disease or hepatic neoplasm;

• Known copper storage disease;

• Known hypersensitivity to any component of the levonorgestrel IUD (LNG IUD) or copper IUD (C-IUD) or latex allergy

• Pregnant or desiring pregnancy in next 24 months

• Gross cervical lesion concerning for neoplasia

• CD4 lymphocyte count<350 cells/mm3 if not using ART

• Less than 6 weeks postpartum

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Device:
• Mirena levonorgestrel IUD
Intrauterine contraception system
• Copper T-380a IUD
intrauterine contraception system

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape Province

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	City University of New York, School of Public Health, University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)	Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.	Enrollment to 24 months
Secondary	Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)	The proportion of women using ART at enrollment with detectable plasma HIV RNA viral load. Viral load assays detected HIV RNA levels at 20-40 copies/mL as the lower limit of detection. The outcome measure coded values above that limit as detectable and those below as undetectable for women using ART and in mean viral load for women not using ART.	Enrollment to 24 months
Secondary	Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety	Participant hemoglobin measured at baseline, 6, 12, 18, and 24 months with blood sample with mean hemoglobin calculated and trends over time assessed. Other safety measures were included with this secondary outcome, such as adverse events, summarized with descriptive statistics.	Enrollment to 24 months
Secondary	Participants Continuing Use of the Allocated Intrauterine Device (IUD)	Measure of the number of women continuing to use the allocated intrauterine device (IUD) across all visits as a measure of acceptability. Proportion of women using the allocated IUD measured at each scheduled visit with time using the IUD adjusted for discontinuation at unscheduled visits. Continuation rate analyzed longitudinally with Kaplan-Meier survival analysis.	Enrollment to 24 months
Secondary	HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method	Proportion of specimens with quantifiable genital viral load compared by specific sampling method (menstrual cup, endocervical swab, and swab-enriched lavage) at enrollment, 3 months and 6 months among women not using antiretroviral therapy (ART). Allocated intrauterine device (IUD) was not considered in this analysis.	6 months