Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Pregnancy incidence - rate of pregnancy that occurs per 12 months
研究概览
简要总结
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.
详细描述
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
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To determine uptake (and adherence, when applicable) of each component of an integrated safer conception intervention among HIV-1 serodiscordant couples, including:
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Use of PrEP by the HIV-1 uninfected partner
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Use of ART by the HIV-1 infected partner
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Menstrual cycle monitoring
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Patterns of condom use
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STI treatment
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Medical male circumcision, and
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Vaginal self-insemination
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To determine rates of pregnancy and HIV-1 incidence among HIV-1 serodiscordant couples participating in a safer conception intervention pilot
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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
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To obtain user feedback about mHealth tools designed to improve patient experience with safer conception including:
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Women's experiences tracking fertility signs through SMS and
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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
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Women and men's experiences receiving SMS messages with personalized safer conception reminders
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To assess participant experiences with an mHealth-enhanced safer conception intervention
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PrEP (Drug)
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.
干预措施: Counseling on timed condomless sex, ART and PrEP adherence (Behavioral)
结局指标
主要结局
Pregnancy incidence - rate of pregnancy that occurs per 12 months
时间窗: 12 months post enrollment
Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner
次要结局
- HIV-1 incidence - rate of new HIV infections that occur per 12 months(12 months post enrollment)
研究者
Renee Heffron
Assistant Professor
University of Washington