Trial Outcomes & Findings for Integrating Safer Conception Counseling to Transform HIV Family Planning Services (NCT NCT03167879)
NCT ID: NCT03167879
Last Updated: 2022-11-21
Results Overview
Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
389 participants
Primary outcome timeframe
Month 12
Results posted on
2022-11-21
Participant Flow
Unit of analysis: clinics
Participant milestones
| Measure |
SCC1--high Intensity Supervision
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
|---|---|---|---|
|
Overall Study
STARTED
|
129 2
|
130 2
|
130 2
|
|
Overall Study
COMPLETED
|
122 2
|
125 2
|
122 2
|
|
Overall Study
NOT COMPLETED
|
7 0
|
5 0
|
8 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrating Safer Conception Counseling to Transform HIV Family Planning Services
Baseline characteristics by cohort
| Measure |
SCC1--high Intensity Supervision
n=129 Participants
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
n=130 Participants
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
n=130 Participants
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.2 • n=99 Participants
|
35.3 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
37.1 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
35.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
195 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
194 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
389 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
129 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
389 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Uganda
|
129 participants
n=99 Participants
|
130 participants
n=107 Participants
|
130 participants
n=206 Participants
|
389 participants
n=7 Participants
|
|
Currently on ART
Currently on ART
|
129 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
385 Participants
n=7 Participants
|
|
Currently on ART
Not currently on ART
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Undetectable HIV viral load
Last viral load was undetectable
|
90 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
265 Participants
n=7 Participants
|
|
Undetectable HIV viral load
Last viral load was not undetectable
|
39 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: 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.
Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention
Outcome measures
| Measure |
SCC1--high Intensity Supervision
n=129 Participants
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
n=130 Participants
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
n=130 Participants
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
|---|---|---|---|
|
Number of Participants Who Used Dual Contraception or Safer Conception Method
|
35 Participants
|
19 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: Analysis conducted only among those trying to conceive (n=276)
Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation
Outcome measures
| Measure |
SCC1--high Intensity Supervision
n=104 Participants
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
n=87 Participants
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
n=85 Participants
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
|---|---|---|---|
|
Number Who Achieved Desired Pregnancy Status
|
32 Participants
|
29 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: study end point (Month 12 or when learning of pregnancy)Population: The primary analyses followed an intent-to-treat (ITT) approach (i.e., outcomes with missing data are designated as having negative outome)
Partner HIV status as determined by HIV antibody test conducted by study
Outcome measures
| Measure |
SCC1--high Intensity Supervision
n=129 Participants
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
n=130 Participants
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
n=130 Participants
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
|---|---|---|---|
|
Partner HIV Status
Number who tested HIV-positive
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Partner HIV Status
Number who tested HIV-negative
|
129 Participants
|
129 Participants
|
130 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 months of intervention implementationPopulation: The primary analyses followed an intent-to-treat (ITT) approach. Cost-effectiveness data were not collected for the usual care arm.
We tracked all costs associated with implementing SCC1 and SCC2 beyond those of existing FP services, such as labor costs associated with SCC sessions and consults with FP nurses, supervision of the FP nurses (in SCC1), contraceptives and SCM client kits, and cost of intervention materials (posters, SCM instructional videos). We assessed the costs for accurate use of SCM on its own among those trying to conceive. Because supervisors in SCC1 were research staff with significantly higher salaries than the MoH supervisors in SCC2, we conducted an additional more realistic "scale-up scenario" showing the costs of SCC1 if its supervisors' salaries were the same as the MoH supervisors' salaries. The cost-effectiveness ratio was calculated as the cost per participant divided by the relative effect size in that group compared to the usual care control.
Outcome measures
| Measure |
SCC1--high Intensity Supervision
n=129 Participants
Integration of safer conception counseling into family planning services, with intensive training and supervision
safer conception counseling: 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.
|
SCC2-- Low Intensity Supervision
n=130 Participants
Integration of safer conception counseling into family planning services, with less intensive training and supervision that mimics Ministry of Health approach
safer conception counseling: 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.
|
Usual Care Family Planning Services
Family planning services that are currently available as part of usual care, which focus almost solely on contraception and pregnancy prevention
|
|---|---|---|---|
|
Cost-effectiveness of Safer Conception Counseling Intervention
|
520 US dollars
Standard Deviation 78
|
1014 US dollars
Standard Deviation 152
|
—
|
Adverse Events
SCC1--high Intensity Supervision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SCC2-- Low Intensity Supervision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Family Planning Services
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place