Safer Conception Intervention TrialNCT03167879

Integrating Safer Conception Counseling to Transform HIV Family Planning Services

A study testing safer conception counseling in people with Safer Conception Intervention Trial, run by RAND at 1 site in Uganda.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 15 to 60 years
Conditions the study is for: Safer Conception Intervention Trial
What is being tested?: safer conception counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 389 participants
Where: 1 siteUganda
Study dates: 15 Jun 2017to 23 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

HIV+ client of TASO
Client if of reproductive age (males age 15-60; females age 15-45).
Has a partner with whom the client is considering having a child.
If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
Partner with whom the client is considering having a child is HIV-negative.
5. Client reports that their partner is aware of the client being HIV-positive.

Who cannot join

1. Female client (or partner of male client) is pregnant

Trial locations and contacts

1 site in 1 country.

Uganda1 site

TASO
Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri

Other trials in Uganda

About this study

Official title: Integrating Counseling to Transform HIV Family Planning Services

This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.

Read the detailed description

Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to support safer conception, despite ~40% of HIV+ women in sub-Saharan Africa (SSA) becoming pregnant post HIV diagnosis. Antiretroviral therapy (ART) greatly reduces the transmission risks associated with childbearing, but many PLHA are either not on ART or not adequately adherent; hence the need for using safer conception methods (SCM) such as manual self-insemination and timed unprotected intercourse. This cluster RCT will compare (1) a comprehensive FP program that incorporates a structured, multi-component SCC intervention (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at 6 HIV clinics operated by TASO Uganda. The 3-arm design, together with the planned cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP services that differ on level of intensity, thereby informing MoH policy and resource allocation. Sixty clients in HIV serodiscordant relationships who express childbearing desires at recruitment will be enrolled at each site (n=360) and followed for 12 months or completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those trying to conceive) or dual contraception (those who decide against pregnancy).

Conditions: Safer Conception Intervention Trial
Being tested: safer conception counseling
Keywords: family planning, safer conception, HIV, serodiscordant couples, Uganda, contraception

What participants receive

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

safer conception counselingBehavioural
Also called SCC
Multi-component counseling to help HIV-affected couples to make an informed decision about childbearing, and to provide counseling to use contraception or safer conception methods, depending on whether the couples chooses to seek or prevent pregnancy after initial consultation.

Study groups in NCT03167879
Study group	Role	What they receive
SCC1--high intensity supervision	Experimental	Integration of safer conception counseling into family planning services, with intensive training and supervision Receives: Behavioral: safer conception counseling
SCC2-- low intensity supervision	Experimental	Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach Receives: Behavioral: safer conception counseling
Usual care family planning services	No intervention	Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention

What is being measured

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

Number of Participants Who Used Dual Contraception or Safer Conception Method
Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention
Measured: Month 12

Secondary outcomes (2)

Number Who Achieved Desired Pregnancy Status
Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation
Measured: Month 12
Partner HIV Status
Partner HIV status as determined by HIV antibody test conducted by study
Measured: study end point (Month 12 or when learning of pregnancy)

Timeline

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

15 Jun 201723 May 2020

First posted30 May 2017
Study start15 Jun 2017
Primary completion23 May 2020
Study completion23 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Safer Conception Intervention TrialStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: This 3-arm cluster RCT will compare (1) a multi-component intervention that integrates safer conception counseling (SCC) into existing family planning (FP) services and provides intensive training and supervision (SCC1), (2) the integration of the same intervention as in (1) into FP services but with a less intensive training and supervision model that mimics the Ministry of Health approach, and (3) usual care FP services, at 6 HIV clinics (2 per arm) operated by TASO Uganda. The model is factorial because the two active intervention arms will be combined and compared to usual care in some analyses.
Masking: None (open label)
Enrolment: 389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03167879
Sponsor's protocol ID: 2016-0560
Other IDs: R01HD090981
Status last verified: Oct 2022
First submitted: 23 May 2017
Last updated: 21 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A data sharing plan is in place to provide a de-identified dataset to researchers who request access or through an NIH-affiliated repository

Publications

Wagner GJ, Wanyenze RK, Beyeza-Kashesya J, Gwokyalya V, Hurley E, Mindry D, Finocchario-Kessler S, Nanfuka M, Tebeka MG, Saya U, Booth M, Ghosh-Dastidar B, Linnemayr S, Staggs VS, Goggin K. "Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches. Implement Sci. 2021 Apr 15;16(1):41. doi: 10.1186/s13012-021-01109-z.
PubMed 33858462
Wagner GJ, Mindry D, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Wanyenze RK, Nanfuka M, Tebeka MG, Goggin K. Reproductive intentions and corresponding use of safer conception methods and contraception among Ugandan HIV clients in serodiscordant relationships. BMC Public Health. 2021 Jan 19;21(1):156. doi: 10.1186/s12889-021-10163-7.
PubMed 33468072
Goggin K, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Birungi J, Mindry D, Wanyenze RK, Wagner GJ. Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda. Implement Sci. 2018 Aug 14;13(1):110. doi: 10.1186/s13012-018-0793-y.
PubMed 30107843

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrating Counseling to Transform HIV Family Planning Services
ClinicalTrials.gov ID: NCT03167879
Acronym / sponsor ID: 2016-0560
Conditions: Safer Conception Intervention Trial
Keywords: family planning, safer conception, HIV, serodiscordant couples, Uganda, contraception
Study type: Interventional
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Children's Mercy Hospital Kansas City, Makerere University, The AIDS Support Organization, University of Kansas, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 15 Jun 2017 (actual)
Primary completion: 23 May 2020 (actual)
Study completion: 23 May 2020 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 21 Nov 2022

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

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3
Model description: This 3-arm cluster RCT will compare (1) a multi-component intervention that integrates safer conception counseling (SCC) into existing family planning (FP) services and provides intensive training and supervision (SCC1), (2) the integration of the same intervention as in (1) into FP services but with a less intensive training and supervision model that mimics the Ministry of Health approach, and (3) usual care FP services, at 6 HIV clinics (2 per arm) operated by TASO Uganda. The model is factorial because the two active intervention arms will be combined and compared to usual care in some analyses.

Arm	Type	Receives
SCC1--high intensity supervision	Experimental	Behavioral: safer conception counselingIntegration of safer conception counseling into family planning services, with intensive training and supervision
SCC2-- low intensity supervision	Experimental	Behavioral: safer conception counselingIntegration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
Usual care family planning services	No intervention	–Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention

Who may qualify

Ages: 15 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

HIV+ client of TASO
Client if of reproductive age (males age 15-60; females age 15-45).
Has a partner with whom the client is considering having a child.
If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
Partner with whom the client is considering having a child is HIV-negative.

Key exclusion criteria (1 listed)

1. Female client (or partner of male client) is pregnant

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
safer conception counselingAlso: SCCMulti-component counseling to help HIV-affected couples to make an informed decision about childbearing, and to provide counseling to use contraception or safer conception methods, depending on whether the couples chooses to seek or prevent pregnancy after initial consultation.	Behavioural	SCC1--high intensity supervision, SCC2-- low intensity supervision

Primary outcome

Number of Participants Who Used Dual Contraception or Safer Conception Method
Time frame: Month 12
Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention

2 secondary outcomes

Number Who Achieved Desired Pregnancy Status
Time frame: Month 12
Partner HIV Status
Time frame: study end point (Month 12 or when learning of pregnancy)

Results and safety

Results posted to the registry on 21 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCC1--high Intensity Supervision	129	122
SCC2-- Low Intensity Supervision	130	125
Usual Care Family Planning Services	130	122

Primary outcome: Number of Participants Who Used Dual Contraception or Safer Conception Method

Time frame: Month 12. Count of participants. Unit: Participants

Measure	SCC1--high Intensity Supervision n = 129	SCC2-- Low Intensity Supervision n = 130	Usual Care Family Planning Services n = 130
Value	35	19	9

SCC1--high Intensity Supervision vs SCC2-- Low Intensity Supervision vs Usual Care Family Planning Services: Odds Ratio (OR): 10.63 (95% CI 2.79 to 40.49)

Population analysed: The primary analyses followed an intent-to-treat (ITT) approach (i.e., outcomes with missing data are designated as not engaging in the desired behavior or achieving the desired pregnancy status); therefore, all participants were included in analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 month study participation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCC1--high Intensity Supervision	0 of 129 (0%)	0 of 129 (0%)	0 of 129
SCC2-- Low Intensity Supervision	0 of 130 (0%)	0 of 130 (0%)	0 of 130
Usual Care Family Planning Services	0 of 130 (0%)	0 of 130 (0%)	0 of 130

Limitations and caveats (from the sponsor): No survey data were collected from the partner of the index participant, except for female partners of male participants who were briefly interviewed on contraception use. Data reported by the female partners were recorded as data for the male participant. These female partner participants are not included in the number enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33858462Wagner GJ, Wanyenze RK, Beyeza-Kashesya J, Gwokyalya V, Hurley E, Mindry D, Finocchario-Kessler S, Nanfuka M, Tebeka MG, Saya U, Booth M, Ghosh-Dastidar B, Linnemayr S, Staggs VS, Goggin K. "Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches. Implement Sci. 2021 Apr 15;16(1):41. doi: 10.1186/s13012-021-01109-z.
Derived from this study: PubMed 33468072Wagner GJ, Mindry D, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Wanyenze RK, Nanfuka M, Tebeka MG, Goggin K. Reproductive intentions and corresponding use of safer conception methods and contraception among Ugandan HIV clients in serodiscordant relationships. BMC Public Health. 2021 Jan 19;21(1):156. doi: 10.1186/s12889-021-10163-7.
Derived from this study: PubMed 30107843Goggin K, Hurley EA, Beyeza-Kashesya J, Gwokyalya V, Finocchario-Kessler S, Birungi J, Mindry D, Wanyenze RK, Wagner GJ. Study protocol of "Our Choice": a randomized controlled trial of the integration of safer conception counseling to transform HIV family planning services in Uganda. Implement Sci. 2018 Aug 14;13(1):110. doi: 10.1186/s13012-018-0793-y.
Individual participant dataSharing planned: Yes. A data sharing plan is in place to provide a de-identified dataset to researchers who request access or through an NIH-affiliated repository

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.

Glenn Wagner, PhD principal investigator

RAND

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

Questions about this trial

What is this clinical trial studying?

A study testing safer conception counseling in people with Safer Conception Intervention Trial, run by RAND at 1 site in Uganda.

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 6 inclusion and 1 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 21 Nov 2022. 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 Uganda. 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?

Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Used Dual Contraception or Safer Conception Method (time frame: Month 12). 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 NCT03167879, which also lists 3 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 21 Nov 2022.