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

An observational study of HIV Infections, run by University of California, San Francisco at 1 site in Zimbabwe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: PrEP (Truvada), Antiretrovirals and Semen washing
Type of treatment: Pill or oral medicine, Surgery or procedure
How many people: 46 participants
Where: 1 siteZimbabwe
Study dates: 13 Mar 2017to 31 Jul 2019
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 35 years
All sexes
Healthy volunteers accepted
Adult

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

Who may be able to join

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;

Show all 13Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Zimbabwe1 site

UZCHS-UCSF CTRC Zengeza Clinical Research Site
Harare

Other trials in Zimbabwe

About this study

Official title: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples

Read the detailed description

The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.

Conditions: HIV Infections
Being tested: PrEP (Truvada), Antiretrovirals, Semen washing, Artificial vaginal insemination
Keywords: HIV-discordant couple, ART, PrEP, semen washing, artificial vaginal insemination, safer conception, pregnancy
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrEP (Truvada)Drug
Also called emtricitabine/tenofovir disoproxil fumarate
oral, daily Truvada for HIV-negative participants
AntiretroviralsDrug
Also called ART
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
Semen washingProcedure or surgery
collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination
Artificial vaginal inseminationProcedure or surgery
collection of semen from an HIV-negative man, followed by intravaginal insemination

Study groups in NCT03049176
Study group	Role	What they receive
HIV+male/HIV-female		discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing Receives: 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 Receives: Drug: PrEP (Truvada); Drug: Antiretrovirals; Procedure: Artificial vaginal insemination

What is being measured

The primary outcome is the main question the study is designed to answer.

Uptake of safer conception strategies
proportion of couples choosing the strategy
Measured: 12 months
Acceptability of safer conception strategies
proportion of couples remaining on strategy; reports of satisfaction
Measured: 12 months
Adherence to safer conception strategies
proportion of couples with high adherence to strategy
Measured: 12 months

Secondary outcomes (4)

Effectiveness of safer conception strategies on HIV prevention
incidence of HIV
Measured: 12 months
Effectiveness of safer conception strategies on achieving pregnancy
incidence of pregnancy
Measured: 12 months
costs of providing safer conception services
costs
Measured: 12 months
cost-effectiveness of safer conception strategies
model the cost effectiveness of various combinations of safer conception strategies
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201731 Jul 2019

First posted9 Feb 2017 (estimated)
Study start13 Mar 2017
Primary completion3 Jun 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03049176
Sponsor's protocol ID: A126763
Other IDs: K01MH100994
Acronym: SAFER
Status last verified: Sep 2019
First submitted: 7 Feb 2017
Last updated: 30 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be made available at the end of the study on an online repository.

Publications

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.
PubMed 36963004
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.
PubMed 33046066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
ClinicalTrials.gov ID: NCT03049176
Acronym / sponsor ID: SAFER / A126763
Conditions: HIV Infections
Keywords: HIV-discordant couple, ART, PrEP, semen washing, artificial vaginal insemination, safer conception, pregnancy
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: UZ-UCSF Collaborative Research Programme, National Institute of Mental Health (NIMH), Gilead Sciences
Study start: 13 Mar 2017 (actual)
Primary completion: 3 Jun 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 9 Feb 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
HIV+male/HIV-female	–	Drug: PrEP (Truvada), Drug: Antiretrovirals, Procedure: Semen washingdiscordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
HIV+female/HIV-male	–	Drug: PrEP (Truvada), Drug: Antiretrovirals, Procedure: Artificial vaginal inseminationdiscordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant

Key inclusion criteria (13 listed)

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;

Key exclusion criteria (5 listed)

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

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
PrEP (Truvada)Also: emtricitabine/tenofovir disoproxil fumarateoral, daily Truvada for HIV-negative participants	Drug	HIV+female/HIV-male, HIV+male/HIV-female
AntiretroviralsAlso: ARToral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant	Drug	HIV+female/HIV-male, HIV+male/HIV-female
Semen washingcollection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination	Procedure or surgery	HIV+male/HIV-female
Artificial vaginal inseminationcollection of semen from an HIV-negative man, followed by intravaginal insemination	Procedure or surgery	HIV+female/HIV-male

Primary outcome

Uptake of safer conception strategies
Time frame: 12 months
proportion of couples choosing the strategy
Acceptability of safer conception strategies
Time frame: 12 months
proportion of couples remaining on strategy; reports of satisfaction
Adherence to safer conception strategies
Time frame: 12 months
proportion of couples with high adherence to strategy

4 secondary outcomes

Effectiveness of safer conception strategies on HIV prevention
Time frame: 12 months
Effectiveness of safer conception strategies on achieving pregnancy
Time frame: 12 months
costs of providing safer conception services
Time frame: 12 months
cost-effectiveness of safer conception strategies
Time frame: 12 months

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 30 Sep 2019.
Derived from this study: PubMed 36963004Brown 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.
Derived from this study: PubMed 33046066Hughes 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.
Individual participant dataSharing planned: Yes. De-identified data will be made available at the end of the study on an online repository.

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Not yet recruiting
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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.

Joelle M Brown, PhD, MPH principal investigator

University of California, San Francisco

Felix Mhlanga, MBChB, MMed principal investigator

UZ-UCSF Collaborative Research Programme

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by University of California, San Francisco at 1 site in Zimbabwe.

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 13 inclusion and 5 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zimbabwe. 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?

Uptake of safer conception strategies (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT03049176, which also lists 2 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 30 Sep 2019.