The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

NCT03049176 | Completed DMC

• 2 other identifiers: A126763K01MH100994
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

Conditions

HIV Infections

Keywords

HIV-discordant couple; ART; PrEP; semen washing; artificial vaginal insemination; safer conception; pregnancy

Outcome Measures

Primary Outcomes (3)

• Uptake of safer conception strategies

  proportion of couples choosing the strategy

  12 months

• Acceptability of safer conception strategies

  proportion of couples remaining on strategy; reports of satisfaction

  12 months

• Adherence to safer conception strategies

  proportion of couples with high adherence to strategy

  12 months

Secondary Outcomes (4)

• Effectiveness of safer conception strategies on HIV prevention

  12 months

• Effectiveness of safer conception strategies on achieving pregnancy

  12 months

• costs of providing safer conception services

  12 months

• cost-effectiveness of safer conception strategies

  12 months

Study Arms (2)

HIV+male/HIV-female

discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing

Drug: PrEP (Truvada); Drug: Antiretrovirals; Procedure: Semen washing

HIV+female/HIV-male

discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination

Drug: PrEP (Truvada); Drug: Antiretrovirals; Procedure: Artificial vaginal insemination

Interventions

PrEP (Truvada) DRUG

oral, daily Truvada for HIV-negative participants

Also known as: emtricitabine/tenofovir disoproxil fumarate

HIV+female/HIV-male; HIV+male/HIV-female

Antiretrovirals DRUG

oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

Also known as: ART

HIV+female/HIV-male; HIV+male/HIV-female

Semen washing PROCEDURE

collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination

HIV+male/HIV-female

Artificial vaginal insemination PROCEDURE

collection of semen from an HIV-negative man, followed by intravaginal insemination

HIV+female/HIV-male

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant

You may qualify if:

• For all couples:
• Couple expresses a desire to conceive
• Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months
• Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months
• Willing to use at least one safer conception strategy
• For men, age ≥18 years. For women, age 18 - 35 years;
• Able and willing to provide written informed consent
• For HIV-uninfected members of the couple
• HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit
• Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
• For HIV-infected members of the couple
• HIV-positive based on parallel positive HIV rapid tests, based on national algorithm
• No current AIDS-defining illness

You may not qualify if:

• Amenorrheic
• Currently pregnant
• Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.
• History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility
• Currently on any concomitant medication that requires the participant to avoid use of PrEP

Sponsors & Collaborators

• University of California, San Francisco: lead
• UZ-UCSF Collaborative Research Programme: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Gilead Sciences: collaborator

Study Sites (1)

UZCHS-UCSF CTRC Zengeza Clinical Research Site

Harare, Zimbabwe

Location

Related Publications (2)

• Brown JM, Gitome S, Mataveke B, Chirenda T, Matubu A, Chareka G, Chasakara C, Mgodi N, Murombedzi C, Musara P, Makurumure T, Hughes CS, Bukusi E, Cohen CR, Shiboski S, Darbes L, Kahn JG, Rutherford GW, Chirenje ZM, Mhlanga F. Preventing HIV and achieving pregnancy among HIV sero-different couples: Pilot study of a safer conception intervention in Zimbabwe. PLOS Glob Public Health. 2023 Feb 24;3(2):e0000796. doi: 10.1371/journal.pgph.0000796. eCollection 2023.

  PMID: 36963004 DERIVED

• Hughes CS, Brown J, Murombedzi C, Chirenda T, Chareka G, Mhlanga F, Mateveke B, Gitome S, Makurumure T, Matubu A, Mgodi N, Chirenje Z, Kahn JG. Estimated costs for the delivery of safer conception strategies for HIV-discordant couples in Zimbabwe: a cost analysis. BMC Health Serv Res. 2020 Oct 12;20(1):940. doi: 10.1186/s12913-020-05784-4.

  PMID: 33046066 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Anti-Retroviral Agents

Condition Hierarchy (Ancestors)

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; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Joelle M Brown, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Felix Mhlanga, MBChB, MMed

  UZ-UCSF Collaborative Research Programme

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: March 13, 2017
• Primary Completion: June 3, 2019
• Study Completion: July 31, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

ZI (1)