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Clinical Trials

MainTitle

Safer Conception Intervention for HIV-1 Serodiscordant Couples (SCIP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2017 by Renee Heffron, University of Washington

Sponsor
University of Washington

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
John E. Fogarty International Center (FIC)

Information provided by (Responsible Party)
Renee Heffron, University of Washington

ClinicalTrials.gov Identifier
NCT03030768

First received: January 12, 2017
Last updated: January 20, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships. Such couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, this study pilots a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex. Additional strategies for couples include diagnosis and treatment of STIs and male circumcision.

mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans to ease the burden of addressing health problems. This safer conception intervention incorporates mHealth tools to improve couples' experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception. SMS surveys to collect daily information from women about their fertility signs and SMS messages are used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic mobile application is used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, the investigators will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application. Couples with immediate fertility intentions will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence. The study takes place in Thika, Kenya.

Condition Intervention
HIV Seropositivity
Pregnancy, High-Risk

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples

Further study details as provided by Renee Heffron, University of Washington:

Primary Outcome Measures

  • Pregnancy incidence - rate of pregnancy that occurs per 12 months [ Time Frame: 12 months post enrollment ]
    Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner
Secondary Outcome Measures:
  • HIV-1 incidence - rate of new HIV infections that occur per 12 months [ Time Frame: 12 months post enrollment ]
    Rate of new HIV-1 infections among couples
Other Outcome Measures:
  • User feedback about mHealth tools designed to improve patient experience with safer conception [ Time Frame: 12 months post enrollment ]
    Women's experiences tracking fertility signs through SMS. Couples' and provider's experiences using a clinic-based mobile application that encompasses clinical, laboratory and fertility data to improve patient-provider communication about safer conception readiness

Biospecimen Retention: Samples Without DNA
Plasma

Estimated Enrollment: 80
Study Start Date: February 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
HIV-1 serodiscordant couples
Couples where one partner is HIV-1 infected and the other is uninfected, who will receive counseling on timed condomless sex, ART and PrEP adherence. The study intervention focuses on ART use by the HIV-1 infected partner, PrEP (Truvada) use by the HIV-1 uninfected partner, and timed condomless sex during the peri-conception period.
Drug: PrEP

An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex during the peri-conception period.

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

An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex

Detailed Description:

Overall Design This is an open-label, prospective cohort pilot study of HIV-1 serodiscordant couples with immediate fertility desires. The overall goal is to determine uptake and sustained use of safer conception strategies, strategies for HIV-1 risk reduction during periods when couples attempt to conceive a child. The study offers PrEP (daily oral TDF or FTC/TDF) to the HIV-1 uninfected member of the couple, ART to the HIV-1 infected member of the couple, teach women about tracking fertility indicators and predicting upcoming periods of peak fertility, and work with couples to establish their readiness to practice timed condomless sex. mHealth tools will be integrated to capture fertility indicators, sexual behavior, improve patient-provider communication, and remind couples about their upcoming periods with peak fertility. The investigators will conduct mixed-methods work to understand couples experiences practicing safer conception and couples and providers experiences using the mHealth tools.
AIMS

  1. To determine uptake (and adherence, when applicable) of each component of an integrated safer conception intervention among HIV-1 serodiscordant couples, including:
    1. Use of PrEP by the HIV-1 uninfected partner
    2. Use of ART by the HIV-1 infected partner
    3. Menstrual cycle monitoring
    4. Patterns of condom use
    5. STI treatment
    6. Medical male circumcision, and
    7. Vaginal self-insemination
  2. To determine rates of pregnancy and HIV-1 incidence among HIV-1 serodiscordant couples participating in a safer conception intervention pilot
  3. To determine which fertility indicators - including onset of menses, basal body temperature, vaginal mucus characteristics, results from luteinizing hormone tests - are most feasible for Kenyan women in HIV-1 serodiscordant partnerships to monitor via SMS
  4. To obtain user feedback about mHealth tools designed to improve patient experience with safer conception including:
    1. Women's experiences tracking fertility signs through SMS and
    2. Couples' and provider's experiences using a clinic-based tablet application that encompasses clinical, laboratory and fertility data to improve patient-provider communication about safer conception readiness
    3. Women and men's experiences receiving SMS messages with personalized safer conception reminders
    4. To assess participant experiences with an mHealth-enhanced safer conception intervention
    Study procedures:

Clinic visits will take place at screening and enrollment, monthly prior to pregnancy and quarterly during pregnancy, for up to 12 months or the end of pregnancy, whichever comes later. Couples will move from a preparatory period into a peri-conception period once they decide to practice timed condomless sex, based on discussions with study clinicians and counselors. They will move from peri-conception to pregnancy once pregnancy occurs or from peri-conception to study exit if pregnancy does not occur within 12 months of study enrollment. During the preparatory and peri-conception periods, women will receive daily SMS surveys.
Screening:
At screening, both members of couples will undergo HIV-1 testing to verify HIV-1 serodiscordancy and women will have a pregnancy test. Demographic, behavioral and medical information will be collected, along with additional laboratory results to establish eligibility (for HIV-1 uninfected partners - serum creatinine, hepatitis B surface antigen). Couples' fertility desires will be assessed and medical history will include information about current use of contraceptives and menstrual cycle regularity.
Enrollment:
At enrollment, members of couples will separately complete interviewer-administered questionnaires to assess their pre-intervention knowledge, perceptions of, and barriers to safer conception strategies and gather data on their demographic and medical characteristics, sexual behavior and any current contraception and/or antiretroviral use. Both partners will undergo diagnostic testing and treatment of genital infections, including gonorrhea, chlamydia, trichomonas, and bacterial vaginosis (BV, if there are symptoms). HIV-1 uninfected partners will be re-tested to verify their HIV-1 status and assessed for acute HIV-1 infection. Women will be tested for pregnancy. HIV-1 infected partners will have specimen collected for CD4 and plasma viral load quantification. Physical exams will be conducted for both partners. Social harm will also be assessed in a culturally appropriate manner and captured on validated case report forms. Safer conception behavioral counseling will be in addition to couples counseling for HIV-1 prevention that fosters an understanding of HIV-1 serodiscordancy and negotiation of safer sex.
Daily SMS surveys:
The day after enrollment, women will begin to receive daily SMS surveys to assess fertility signs and sexual behavior.
Follow up visits:
Participants will complete follow up visits to track their compliance with the intervention strategies and study procedures. Participants will be scheduled for monthly study visits during the preparatory and peri-conception periods and quarterly during pregnancy. Participants can move from the preparatory period to peri-conception based on their own desires and counseling from a clinician.
Exit:
Following the end of pregnancy or 12 months after study enrollment (whichever is later), couples will be exited from the study. At study exit, couples will be counseled about their current fertility goals (which may have changed throughout the course of follow up, especially for couples who become pregnant and have a child during the study period) and offered contraception and referrals for ongoing services, as appropriate.
Qualitative interviews:
To gain a deeper understanding of how participants perceive the integrated safer conception intervention and the mHealth components that are part of the intervention, we will conduct in-depth interviews with up to 40 couples. Interview topics will include: identification of factors influencing individuals' preferences for safer conception strategies, their experience with safer conception strategies, and their intentions for continued use of these strategies should they desire pregnancy again and user satisfaction with the mHealth tools and suggestions for improvement.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 49 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

Heterosexual HIV-1 serodiscordant couples in Thika, Kenya with immediate fertility desires, who did not participate in a previous study "Partners PrEP Study or the Partners Demonstration Project" at the site, and study clinicians and counselors delivering the intervention.

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03030768

Contacts

Contact:   Renee Heffron, PhD 206-520-3817 rheffron@uw.edu
Contact:   Nelly Mugo, MBchB, MPH +2542736744 rwamba@csrtkenya.org

Locations

United States, Washington
University of Washington, Coordinating Center Recruiting
Seattle, Washington, United States, 98104
Contact: Renee Heffron, PhD    206-520-3817    rheffron@uw.edu
Principal Investigator: Renee Heffron, PhD
Sub-Investigator: Connie Celum, MD, MPH
Sub-Investigator: Jared Baeten, MD, PhD
Kenya
Partners in Health, Research and Development Recruiting
Thika, Kenya
Contact: Kenneth Ngure, PhD    +2546722561    kngure@pipsthika.org
Contact: Nelly Mugo, MBchB, MPH    +2542736744    rwamba@csrtkenya.org
Sub-Investigator: Kenneth Ngure, PhD
Principal Investigator: Nelly Mugo, MBchB, MPH

Sponsors and Collaborators

University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
John E. Fogarty International Center (FIC)

Investigators

Study Chair: Renee Heffron, PhD University of Washington
More Information

More Information


Responsible Party: Renee Heffron, Assistant Professor, University of Washington  
ClinicalTrials.gov Identifier: NCT03030768   History of Changes  
Other Study ID Numbers: 49487J  
  R00HD076679  
  R21TW009908  
Study First Received: January 12, 2017  
Last Updated: January 20, 2017  
Individual Participant Data    
Plan to Share IPD: Yes  

Keywords provided by Renee Heffron, University of Washington:

Pre-Exposure Prophylaxis
Fertility
mHealth
Pregnancy

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.