Safer Conception Intervention for HIV-1 Serodiscordant Couples

NCT03030768 | Completed

• 3 other identifiers: STUDY00002068R00HD076679R21TW009908
• Study Type: observational
• Target: 74
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV Seropositivity; Pregnancy, High-Risk

Keywords

Pre-Exposure Prophylaxis; Fertility; mHealth; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pregnancy incidence - rate of pregnancy that occurs per 12 months

  Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner

  12 months post enrollment

Secondary Outcomes (1)

• HIV-1 incidence - rate of new HIV infections that occur per 12 months

  12 months post enrollment

Other Outcomes (1)

• User feedback about mHealth tools designed to improve patient experience with safer conception

  12 months post enrollment

Study Arms (1)

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

Interventions

PrEP DRUG

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.

Also known as: Truvada

HIV-1 serodiscordant couples

Counseling on timed condomless sex, ART and PrEP adherence BEHAVIORAL

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

HIV-1 serodiscordant couples

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

University of Washington, Coordinating Center

Seattle, Washington, 98104, United States

Location

Partners in Health, Research and Development

Thika, Kenya

Location

Related Publications (11)

• 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.

  PMID: 22595872 BACKGROUND

• Ngure 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.

  PMID: 24779445 BACKGROUND

• Guidance 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/

  PMID: 23700649 BACKGROUND

• Irungu 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.

  PMID: 27751179 BACKGROUND

• Mugo 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.

  PMID: 25038355 BACKGROUND

• Baeten 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.

  PMID: 22784037 BACKGROUND

• Mugo 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.

  PMID: 21785321 BACKGROUND

• Baeten 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.

  PMID: 27552090 BACKGROUND

• Matthews 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.

  PMID: 25118795 BACKGROUND

• Heffron 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.

  PMID: 26993627 BACKGROUND

• Heffron 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.

  PMID: 30957420 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Renee Heffron, PhD

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 25, 2017
• Study Start: February 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

KE (1); US (1)