Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT03030768
Eligibility Criteria:
Inclusion Criteria:
* Couples
* Immediate fertility intention
* Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
* Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
For HIV-1 infected members of the couple (index participants)
* Able and willing to provide written informed consent
* HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
* Not currently pregnant or breastfeeding
* No use of injectable contraception for the past 3 months
* Not currently enrolled in an HIV-1 treatment study
* No clear indication of infertility or subfertility, as determined by medical history
* Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 uninfected partner
* Know how to send and receive SMS
* Have regular access to electricity or an alternative means for charging a cell phone Literate in English, Kiswahili or Kikuyu
For HIV-1 uninfected members of the couple (partner participants)
* Able and willing to provide written informed consent
* HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
* Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
* Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
* Not currently pregnant or breastfeeding
* No use of injectable contraception for the past 3 months
* Not currently enrolled in an HIV-1 prevention clinical trial
* Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
* No clear indication of infertility or subfertility, as determined by medical history
* Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 infected partner
* Know how to send and receive SMS
* Have regular access to electricity or an alternative means for charging a cell phone
* Literate in English, Kiswahili or Kikuyu
For study clinicians and counselors
• Active involvement in safer conception counseling for couples and use of the tablet application during counseling sessions
Exclusion Criteria:
* For couples
* Participated in the Partners PrEP Study or the Partners Demonstration Project For HIV-1 infected members of the couple (index participants)
* Currently pregnant or breastfeeding
* Used an injectable contraception in the past 3 months
* Currently enrolled in an HIV-1 treatment study
* Has a clear indication of infertility or sub-fertility, as determined by medical history
For HIV-1 uninfected members of the couple (partner participants):
* Infected with hepatitis B virus, as determined by a positive hepatitis B surface antigen test
* Currently pregnant or breastfeeding
* Used an injectable contraception in the past 3 months
* Currently enrolled in an HIV-1 prevention clinical trial
* Has a clear indication of infertility or subfertility, as determined by medical history
* Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03030768
Study Brief:
Protocol Section:
NCT03030768