HIV InfectionsFP-ARTNCT03153709
Prospective Cohort Evaluating Pregnancy Rates, PK Interactions Among HIV+ Women on EFV Initiating LNG Implant or DMPA
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The purpose of this study is to compare the pregnancy rates among women who are using the HIV drug Efavirenz and either the birth control injection or implant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- HIV Infections
- How many people
- 1,382 participants
- Where
- 1 siteMalawi
- Study dates
- 17 Aug 2017to 10 Dec 2021
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 710 HIV-infected women on EFV who are initiating the LNG implant and 710 HIV-infected women on EFV who are initiating the DMPA injectable
Who may be able to join
- Age 18-40 years
- Documented HIV-infected status
- Current use of EFV
- Fluency in English or Chichewa (the most commonly-spoken language in Malawi)
- Not currently pregnant (to be confirmed by urine pregnancy test)
- Initiation of DMPA or the LNG implant within the past 28 days (to be confirmed by verification in the woman's Health Passport and palpation of the implant if applicable)
Show all 9Show fewer
- No use of their current contraceptive during the 3 months before they recently initiated it (i.e., they must be newly starting and not just continuing their chosen contraceptive)
- No desire for pregnancy in the next 4 years
- Most recent HIV VL <1,000 copies/mL (as per Malawi guidelines, women who have VL ≥1,000 copies/mL will need to be referred for possible 2nd-line ART without EFV)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Evaluating the Pregnancy Rates and Pharmacokinetic Interactions Among HIV-infected Malawian Women on Efavirenz Initiating the Levonorgestrel Implant or the Depot Medroxyprogesterone Acetate Injectable
The purpose of this study is to compare the pregnancy rates among women who are using the HIV drug Efavirenz and either the birth control injection or implant.
Read the detailed description
Objective 1: To compare the typical-use pregnancy rates of 710 HIV+ DMPA-users on EFV with 710 HIV+ LNG implant users on EFV through a prospective observational cohort.
The investigators will enroll 710 HIV-infected women on EFV who are initiating the LNG implant and 710 HIV-infected women on EFV who are initiating the DMPA injectable and follow them 1 month after contraceptive initiation and then every 6 months until the end of the 4-year study time period. The investigators will recruit and enroll over a period of 2 years; those who are enrolled at the beginning of the enrollment period may complete up to 4 years of follow-up, whereas those who are enrolled at the end of the 2-year enrollment period will complete 2 years of follow-up. Women will have urine, blood, and hair specimens obtained at each study visit. The primary outcome will be incident pregnancy, evaluated by urine pregnancy testing. The secondary outcome will be contraceptive continuation, evaluated by palpation (for LNG implant) and review of the woman's medical record and study forms (for DMPA). A marginal structural Poisson model will be used to estimate the effect of implant compared to DMPA upon pregnancy incidence. The investigators will adjust for key potential confounders, including frequency of intercourse, age, and body mass index (BMI).
Objective 2: To assess whether greater EFV exposure (measured by hair concentrations) is associated with contraceptive failure in LNG implant users in a 2:1 nested case-control study of 240 LNG implant users.
The investigators estimate that a maximum of 120 pregnancies will occur among LNG implant users in the cohort in Objective 1. From this cohort, the investigators will compare 80 pregnant women who were using the LNG implant at the time of conception and 160 controls who had intercourse during the previous 3 months and were not pregnant after a similar period of LNG implant use. A conditional logistic regression model will be used to assess the association between EFV hair concentrations and contraceptive failure; key potential confounders the investigators will adjust for in the analysis include frequency of intercourse, age, weight, and length of time on EFV. The data for this Objective's exposure, outcome, and confounders will be derived from the Data Collection Forms and study specimens obtained in Objective 1.
Objective 3: To evaluate the effect of EFV 400 mg daily on LNG concentrations among a subset of 25 women enrolled in the prospective cohort study who initiated the LNG implant.
The investigators plan to enroll 25 of the 710 EFV users from their prospective cohort in Objective 1 who are initiating the LNG implant into the pharmacokinetic sub-study. All 25 of these women will be enrolled from 1 health facility, Area 18 Health Centre, and all women will be taking EFV 400 mg daily, which is the standard dose that Malawi will be implementing this year due to its equivalent efficacy but decreased cost and side effects when compared to EFV 600 mg daily. Follow-up visits for women in the sub-study will be conducted at 4, 12, 24, 36, and 48 weeks post-implant initiation. Since these women would already be attending visits at 4, 24, and 48 weeks post-implant initiation, there will only be 2 extra study visits for these sub-study participants at 12 weeks post-implant initiation (Visit 1a) and 36 weeks post-implant initiation (Visit 2a). During the extra Visits 1a and 2a, urine, blood, and hair specimens will be obtained so that pregnancy testing can be performed and blood and hair can be stored for VL, EFV, and LNG testing.
- Conditions
- HIV Infections
- Keywords
- Pregnancy rates, pharmacokinetic interactions, Women on efavirenz, initiating the Levonorgestrel Implant, initiating the Depot Medroxyprogesterone Acetate Injectable
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates of 710 HIV+ DMPA-users on EFV
urine pregnancy testing
Measured: 4 years
pregnancy rates of 710 HIV+ LNG implant users on EFV
urine pregnancy testing
Measured: 4 years
EFV concentration from blood
A validated HPLC-UV assay for EFV will be used for plasma analysis. Concentrations of EFV in a range of 10 to 10,000 ng/mL will be analyzed.
Measured: 4 years
EFV concentration from hair
Using an IR-MALDESI imaging source coupled to a Thermo Q-Exactive/H-ESI II Bundle mass spectrometer, ~1 cm samples of hair, which will give resultant band intensities over the hair will be analyzed. EFV concentrations at each band intensity will be quantified based on a standard curve.64 Both the total and average concentrations over the 6-month period will be analyzed.
Measured: 4 years
The LNG concentrations from serum
The sensitivity of the LNG is 0.05 ng/ml, and the intraassay and interassay coefficients of variation (CVs) are 4.4% and 8.9%.
Measured: 4 years
HIV viral load from plasma
HIV RNA in the range of 40-10,000,000 copies/mL
Measured: 4 years
DNA quantitated from whole blood
Using a Qiagen DNA extraction kit for blood, 1uL of whole blood will be processed to obtain DNA. This DNA will be quantitated and 120ng will be used in the assay.
Measured: 4 years
Secondary outcomes (1)
contraceptive continuation
palpation (for LNG implant) and review of the woman's medical record and study forms (for DMPA).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start17 Aug 2017
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jennifer Tang, MD, MSRC, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153709
- Sponsor's protocol ID
- 17-0471
- Other IDs
- 1R01HD088279-01A1, UNCPM-21701
- Acronym
- FP-ART
- Status last verified
- Feb 2022
- First submitted
- 11 May 2017
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Evaluating the Pregnancy Rates and Pharmacokinetic Interactions Among HIV-infected Malawian Women on Efavirenz Initiating the Levonorgestrel Implant or the Depot Medroxyprogesterone Acetate Injectable
- ClinicalTrials.gov ID
- NCT03153709
- Acronym / sponsor ID
- FP-ART / 17-0471
- Conditions
- HIV Infections
- Keywords
- Pregnancy rates, pharmacokinetic interactions, Women on efavirenz, initiating the Levonorgestrel Implant, initiating the Depot Medroxyprogesterone Acetate Injectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,382 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 15 May 2017 (actual)
- 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 purpose of this study is to compare the pregnancy rates among women who are using the HIV drug Efavirenz and either the birth control injection or implant.
Detailed description
Objective 1: To compare the typical-use pregnancy rates of 710 HIV+ DMPA-users on EFV with 710 HIV+ LNG implant users on EFV through a prospective observational cohort.
The investigators will enroll 710 HIV-infected women on EFV who are initiating the LNG implant and 710 HIV-infected women on EFV who are initiating the DMPA injectable and follow them 1 month after contraceptive initiation and then every 6 months until the end of the 4-year study time period. The investigators will recruit and enroll over a period of 2 years; those who are enrolled at the beginning of the enrollment period may complete up to 4 years of follow-up, whereas those who are enrolled at the end of the 2-year enrollment period will complete 2 years of follow-up. Women will have urine, blood, and hair specimens obtained at each study visit. The primary outcome will be incident pregnancy, evaluated by urine pregnancy testing. The secondary outcome will be contraceptive continuation, evaluated by palpation (for LNG implant) and review of the woman's medical record and study forms (for DMPA). A marginal structural Poisson model will be used to estimate the effect of implant compared to DMPA upon pregnancy incidence. The investigators will adjust for key potential confounders, including frequency of intercourse, age, and body mass index (BMI).
Objective 2: To assess whether greater EFV exposure (measured by hair concentrations) is associated with contraceptive failure in LNG implant users in a 2:1 nested case-control study of 240 LNG implant users.
The investigators estimate that a maximum of 120 pregnancies will occur among LNG implant users in the cohort in Objective 1. From this cohort, the investigators will compare 80 pregnant women who were using the LNG implant at the time of conception and 160 controls who had intercourse during the previous 3 months and were not pregnant after a similar period of LNG implant use. A conditional logistic regression model will be used to assess the association between EFV hair concentrations and contraceptive failure; key potential confounders the investigators will adjust for in the analysis include frequency of intercourse, age, weight, and length of time on EFV. The data for this Objective's exposure, outcome, and confounders will be derived from the Data Collection Forms and study specimens obtained in Objective 1.
Objective 3: To evaluate the effect of EFV 400 mg daily on LNG concentrations among a subset of 25 women enrolled in the prospective cohort study who initiated the LNG implant.
The investigators plan to enroll 25 of the 710 EFV users from their prospective cohort in Objective 1 who are initiating the LNG implant into the pharmacokinetic sub-study. All 25 of these women will be enrolled from 1 health facility, Area 18 Health Centre, and all women will be taking EFV 400 mg daily, which is the standard dose that Malawi will be implementing this year due to its equivalent efficacy but decreased cost and side effects when compared to EFV 600 mg daily. Follow-up visits for women in the sub-study will be conducted at 4, 12, 24, 36, and 48 weeks post-implant initiation. Since these women would already be attending visits at 4, 24, and 48 weeks post-implant initiation, there will only be 2 extra study visits for these sub-study participants at 12 weeks post-implant initiation (Visit 1a) and 36 weeks post-implant initiation (Visit 2a). During the extra Visits 1a and 2a, urine, blood, and hair specimens will be obtained so that pregnancy testing can be performed and blood and hair can be stored for VL, EFV, and LNG testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 710 HIV-infected women on EFV who are initiating the LNG implant and 710 HIV-infected women on EFV who are initiating the DMPA injectable
Key inclusion criteria (9 listed)
- Age 18-40 years
- Documented HIV-infected status
- Current use of EFV
- Fluency in English or Chichewa (the most commonly-spoken language in Malawi)
- Not currently pregnant (to be confirmed by urine pregnancy test)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pregnancy rates of 710 HIV+ DMPA-users on EFV
Time frame: 4 years
urine pregnancy testing
pregnancy rates of 710 HIV+ LNG implant users on EFV
Time frame: 4 years
urine pregnancy testing
EFV concentration from blood
Time frame: 4 years
A validated HPLC-UV assay for EFV will be used for plasma analysis. Concentrations of EFV in a range of 10 to 10,000 ng/mL will be analyzed.
EFV concentration from hair
Time frame: 4 years
Using an IR-MALDESI imaging source coupled to a Thermo Q-Exactive/H-ESI II Bundle mass spectrometer, ~1 cm samples of hair, which will give resultant band intensities over the hair will be analyzed. EFV concentrations at each band intensity will be quantified based on a standard curve.64 Both the total and average concentrations over the 6-month period will be analyzed.
The LNG concentrations from serum
Time frame: 4 years
The sensitivity of the LNG is 0.05 ng/ml, and the intraassay and interassay coefficients of variation (CVs) are 4.4% and 8.9%.
HIV viral load from plasma
Time frame: 4 years
HIV RNA in the range of 40-10,000,000 copies/mL
DNA quantitated from whole blood
Time frame: 4 years
Using a Qiagen DNA extraction kit for blood, 1uL of whole blood will be processed to obtain DNA. This DNA will be quantitated and 120ng will be used in the assay.
1 secondary outcome
contraceptive continuation
Time frame: 4 years
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 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Jennifer Tang, MD, MSRC principal investigator
UNC-CH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill 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 9 inclusion and 1 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 Feb 2022. 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?
pregnancy rates of 710 HIV+ DMPA-users on EFV (time frame: 4 years). The study lists 7 primary outcomes in all. 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 Feb 2022.