HIV SeropositivitySCIPNCT03030768
Safer Conception Intervention for HIV-1 Serodiscordant Couples
An observational study of HIV Seropositivity and Pregnancy, High-Risk, run by University of Washington at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, Pregnancy, High-Risk
- What is being tested?
- PrEP and Counseling on timed condomless sex, ART and PrEP adherence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Washington, Coordinating Center
Seattle, Washington, 98104
About this study
Official title: Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples
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.
Read the 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
- To determine uptake (and adherence, when applicable) of each component of an integrated safer conception intervention among HIV-1 serodiscordant couples, including:
- Use of PrEP by the HIV-1 uninfected partner
- Use of ART by the HIV-1 infected partner
- Menstrual cycle monitoring
- Patterns of condom use
- STI treatment
- Medical male circumcision, and
- Vaginal self-insemination
- To determine rates of pregnancy and HIV-1 incidence among HIV-1 serodiscordant couples participating in a safer conception intervention pilot
- 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
- To obtain user feedback about mHealth tools designed to improve patient experience with safer conception including:
- Women's experiences tracking fertility signs through SMS and
- 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
- Women and men's experiences receiving SMS messages with personalized safer conception reminders
- 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.
- Conditions
- HIV Seropositivity, Pregnancy, High-Risk
- Being tested
- PrEP, Counseling on timed condomless sex, ART and PrEP adherence
- Keywords
- Pre-Exposure Prophylaxis, Fertility, mHealth, Pregnancy
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
Also called Truvada
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.
Counseling on timed condomless sex, ART and PrEP adherenceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PrEP; Behavioral: Counseling on timed condomless sex, ART and PrEP adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy incidence - rate of pregnancy that occurs per 12 months
Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner
Measured: 12 months post enrollment
Secondary outcomes (1)
HIV-1 incidence - rate of new HIV infections that occur per 12 months
Rate of new HIV-1 infections among couples
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionMay 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Renee Heffron, University of Washington
- Investigators
- Renee Heffron, PhD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030768
- Sponsor's protocol ID
- STUDY00002068
- Other IDs
- R00HD076679, R21TW009908
- Acronym
- SCIP
- Status last verified
- Sep 2018
- First submitted
- 12 Jan 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all outcome measures will be made available after study completion
Publications
Heffron R, Ngure K, Mugo N, Celum C, Kurth A, Curran K, Baeten JM. Willingness of Kenyan HIV-1 serodiscordant couples to use antiretroviral-based HIV-1 prevention strategies. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):116-9. doi: 10.1097/QAI.0b013e31825da73f.
PubMed 22595872Ngure K, Baeten JM, Mugo N, Curran K, Vusha S, Heffron R, Celum C, Shell-Duncan B. My intention was a child but I was very afraid: fertility intentions and HIV risk perceptions among HIV-serodiscordant couples experiencing pregnancy in Kenya. AIDS Care. 2014;26(10):1283-7. doi: 10.1080/09540121.2014.911808. Epub 2014 Apr 29.
PubMed 24779445Guidance on Couples HIV Testing and Counselling Including Antiretroviral Therapy for Treatment and Prevention in Serodiscordant Couples: Recommendations for a Public Health Approach. Geneva: World Health Organization; 2012 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK138278/
PubMed 23700649Irungu EM, Heffron R, Mugo N, Ngure K, Katabira E, Bulya N, Bukusi E, Odoyo J, Asiimwe S, Tindimwebwa E, Celum C, Baeten JM; Partners Demonstration Project Team. Use of a risk scoring tool to identify higher-risk HIV-1 serodiscordant couples for an antiretroviral-based HIV-1 prevention intervention. BMC Infect Dis. 2016 Oct 17;16(1):571. doi: 10.1186/s12879-016-1899-y.
PubMed 27751179Mugo NR, Hong T, Celum C, Donnell D, Bukusi EA, John-Stewart G, Wangisi J, Were E, Heffron R, Matthews LT, Morrison S, Ngure K, Baeten JM; Partners PrEP Study Team. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):362-71. doi: 10.1001/jama.2014.8735.
PubMed 25038355Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
PubMed 22784037Mugo NR, Heffron R, Donnell D, Wald A, Were EO, Rees H, Celum C, Kiarie JN, Cohen CR, Kayintekore K, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS. 2011 Sep 24;25(15):1887-95. doi: 10.1097/QAD.0b013e32834a9338.
PubMed 21785321Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, Asiimwe S, Haberer JE, Morton J, Ngure K, Bulya N, Odoyo J, Tindimwebwa E, Hendrix C, Marzinke MA, Ware NC, Wyatt MA, Morrison S, Haugen H, Mujugira A, Donnell D, Celum C; Partners Demonstration Project Team. Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016 Aug.
PubMed 27552090Matthews LT, Heffron R, Mugo NR, Cohen CR, Hendrix CW, Celum C, Bangsberg DR, Baeten JM; Partners PrEP Study Team. High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):91-7. doi: 10.1097/QAI.0000000000000246.
PubMed 25118795Heffron R, Pintye J, Matthews LT, Weber S, Mugo N. PrEP as Peri-conception HIV Prevention for Women and Men. Curr HIV/AIDS Rep. 2016 Jun;13(3):131-9. doi: 10.1007/s11904-016-0312-1.
PubMed 26993627Heffron R, Ngure K, Velloza J, Kiptinness C, Quame-Amalgo J, Oluch L, Thuo N, Njoroge J, Momanyi R, Gakuo S, Mbugua S, Morrison S, Haugen H, Chohan B, Celum C, Baeten JM, Mugo N. Implementation of a comprehensive safer conception intervention for HIV-serodiscordant couples in Kenya: uptake, use and effectiveness. J Int AIDS Soc. 2019 Apr;22(4):e25261. doi: 10.1002/jia2.25261.
PubMed 30957420
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples
- ClinicalTrials.gov ID
- NCT03030768
- Acronym / sponsor ID
- SCIP / STUDY00002068
- Conditions
- HIV Seropositivity, Pregnancy, High-Risk
- Keywords
- Pre-Exposure Prophylaxis, Fertility, mHealth, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fogarty International Center of the National Institute of Health
- Study start
- Feb 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To determine uptake (and adherence, when applicable) of each component of an integrated safer conception intervention among HIV-1 serodiscordant couples, including:
- Use of PrEP by the HIV-1 uninfected partner
- Use of ART by the HIV-1 infected partner
- Menstrual cycle monitoring
- Patterns of condom use
- STI treatment
- Medical male circumcision, and
- Vaginal self-insemination
- To determine rates of pregnancy and HIV-1 incidence among HIV-1 serodiscordant couples participating in a safer conception intervention pilot
- 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
- To obtain user feedback about mHealth tools designed to improve patient experience with safer conception including:
- Women's experiences tracking fertility signs through SMS and
- 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
- Women and men's experiences receiving SMS messages with personalized safer conception reminders
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 serodiscordant couples | – | Drug: PrEP, Behavioral: Counseling on timed condomless sex, ART and PrEP adherenceCouples 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (30 listed)
- Couples
- 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
Key exclusion criteria (13 listed)
- For couples
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEPAlso: TruvadaAn 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. | Drug | HIV-1 serodiscordant couples |
| Counseling on timed condomless sex, ART and PrEP adherenceAn 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 | Behavioural | HIV-1 serodiscordant couples |
Primary outcome
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
1 secondary outcome
HIV-1 incidence - rate of new HIV infections that occur per 12 months
Time frame: 12 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Background: PubMed 22595872Heffron R, Ngure K, Mugo N, Celum C, Kurth A, Curran K, Baeten JM. Willingness of Kenyan HIV-1 serodiscordant couples to use antiretroviral-based HIV-1 prevention strategies. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):116-9. doi: 10.1097/QAI.0b013e31825da73f.
- Background: PubMed 24779445Ngure K, Baeten JM, Mugo N, Curran K, Vusha S, Heffron R, Celum C, Shell-Duncan B. My intention was a child but I was very afraid: fertility intentions and HIV risk perceptions among HIV-serodiscordant couples experiencing pregnancy in Kenya. AIDS Care. 2014;26(10):1283-7. doi: 10.1080/09540121.2014.911808. Epub 2014 Apr 29.
- Background: PubMed 23700649Guidance on Couples HIV Testing and Counselling Including Antiretroviral Therapy for Treatment and Prevention in Serodiscordant Couples: Recommendations for a Public Health Approach. Geneva: World Health Organization; 2012 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK138278/
- Background: PubMed 27751179Irungu EM, Heffron R, Mugo N, Ngure K, Katabira E, Bulya N, Bukusi E, Odoyo J, Asiimwe S, Tindimwebwa E, Celum C, Baeten JM; Partners Demonstration Project Team. Use of a risk scoring tool to identify higher-risk HIV-1 serodiscordant couples for an antiretroviral-based HIV-1 prevention intervention. BMC Infect Dis. 2016 Oct 17;16(1):571. doi: 10.1186/s12879-016-1899-y.
- Background: PubMed 25038355Mugo NR, Hong T, Celum C, Donnell D, Bukusi EA, John-Stewart G, Wangisi J, Were E, Heffron R, Matthews LT, Morrison S, Ngure K, Baeten JM; Partners PrEP Study Team. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):362-71. doi: 10.1001/jama.2014.8735.
- Background: PubMed 22784037Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
- Background: PubMed 21785321Mugo NR, Heffron R, Donnell D, Wald A, Were EO, Rees H, Celum C, Kiarie JN, Cohen CR, Kayintekore K, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS. 2011 Sep 24;25(15):1887-95. doi: 10.1097/QAD.0b013e32834a9338.
- Background: PubMed 27552090Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, Asiimwe S, Haberer JE, Morton J, Ngure K, Bulya N, Odoyo J, Tindimwebwa E, Hendrix C, Marzinke MA, Ware NC, Wyatt MA, Morrison S, Haugen H, Mujugira A, Donnell D, Celum C; Partners Demonstration Project Team. Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda. PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016 Aug.
- Background: PubMed 25118795Matthews LT, Heffron R, Mugo NR, Cohen CR, Hendrix CW, Celum C, Bangsberg DR, Baeten JM; Partners PrEP Study Team. High medication adherence during periconception periods among HIV-1-uninfected women participating in a clinical trial of antiretroviral pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):91-7. doi: 10.1097/QAI.0000000000000246.
- Background: PubMed 26993627Heffron R, Pintye J, Matthews LT, Weber S, Mugo N. PrEP as Peri-conception HIV Prevention for Women and Men. Curr HIV/AIDS Rep. 2016 Jun;13(3):131-9. doi: 10.1007/s11904-016-0312-1.
- Derived from this study: PubMed 30957420Heffron R, Ngure K, Velloza J, Kiptinness C, Quame-Amalgo J, Oluch L, Thuo N, Njoroge J, Momanyi R, Gakuo S, Mbugua S, Morrison S, Haugen H, Chohan B, Celum C, Baeten JM, Mugo N. Implementation of a comprehensive safer conception intervention for HIV-serodiscordant couples in Kenya: uptake, use and effectiveness. J Int AIDS Soc. 2019 Apr;22(4):e25261. doi: 10.1002/jia2.25261.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all outcome measures will be made available after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Heffron, PhD study chair
University of Washington
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and Pregnancy, High-Risk, run by University of Washington at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy incidence - rate of pregnancy that occurs per 12 months (time frame: 12 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030768, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.