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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03030768
Date of registration:	12/01/2017
Prospective Registration:	No
Primary sponsor:	University of Washington
Public title:	Safer Conception Intervention for HIV-1 Serodiscordant Couples SCIP
Scientific title:	Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples
Date of first enrolment:	February 2016
Target sample size:	74
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03030768
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Kenya	United States

Contacts

Name:	Renee Heffron, PhD
Address:
Telephone:
Email:
Affiliation:	University of Washington

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 49 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pregnancy, High-Risk

HIV Seropositivity

Intervention(s)

Behavioral: Counseling on timed condomless sex, ART and PrEP adherence

Drug: PrEP

Primary Outcome(s)

Pregnancy incidence - rate of pregnancy that occurs per 12 months [Time Frame: 12 months post enrollment]

Secondary Outcome(s)

HIV-1 incidence - rate of new HIV infections that occur per 12 months [Time Frame: 12 months post enrollment]

Secondary ID(s)

STUDY00002068

R00HD076679

R21TW009908

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Fogarty International Center of the National Institute of Health

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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