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

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ClinicalTrials.gov Identifier: NCT03030768
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
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

Brief Summary:

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 or disease Intervention/treatment
HIV Seropositivity Pregnancy, High-Risk Drug: PrEP Behavioral: Counseling on timed condomless sex, ART and PrEP adherence

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 74 participants
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
Study Start Date : February 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030768


Locations
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United States, Washington
University of Washington, Coordinating Center
Seattle, Washington, United States, 98104
Kenya
Partners in Health, Research and Development
Thika, Kenya
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
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Study Chair: Renee Heffron, PhD University of Washington

Publications:

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Responsible Party: Renee Heffron, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03030768     History of Changes
Other Study ID Numbers: STUDY00002068
R00HD076679 ( U.S. NIH Grant/Contract )
R21TW009908 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available after study completion

Keywords provided by Renee Heffron, University of Washington:
Pre-Exposure Prophylaxis
Fertility
mHealth
Pregnancy

Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases