Safer Conception Intervention Trial
Conditions
Keywords
family planning, safer conception, HIV, serodiscordant couples, Uganda, contraception
Brief summary
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.
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).
Interventions
BEHAVIORALsafer 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.
Sponsors
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)
RAND
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. HIV+ client of TASO 2. Client if of reproductive age (males age 15-60; females age 15-45). 3. Has a partner with whom the client is considering having a child. 4. 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. 5. 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.
Exclusion criteria
1\. Female client (or partner of male client) is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Used Dual Contraception or Safer Conception Method | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Who Achieved Desired Pregnancy Status | Month 12 | Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation |
| Partner HIV Status | study end point (Month 12 or when learning of pregnancy) | Partner HIV status as determined by HIV antibody test conducted by study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of Safer Conception Counseling Intervention | 30 months of intervention implementation | 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. |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 130 |
| 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 | 130 |
| Total | 389 |
Baseline characteristics
| Characteristic | SCC1--high Intensity Supervision | SCC2-- Low Intensity Supervision | Usual Care Family Planning Services | Total |
|---|---|---|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 7.2 | 35.3 years STANDARD_DEVIATION 8 | 37.1 years STANDARD_DEVIATION 9.1 | 35.9 years STANDARD_DEVIATION 8.2 |
| Currently on ART Currently on ART | 129 Participants | 128 Participants | 128 Participants | 385 Participants |
| Currently on ART Not currently on ART | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 130 Participants | 130 Participants | 389 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 129 Participants | 130 Participants | 130 Participants | 389 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 129 participants | 130 participants | 130 participants | 389 participants |
| Sex: Female, Male Female | 78 Participants | 66 Participants | 51 Participants | 195 Participants |
| Sex: Female, Male Male | 51 Participants | 64 Participants | 79 Participants | 194 Participants |
| Undetectable HIV viral load Last viral load was not undetectable | 39 Participants | 52 Participants | 33 Participants | 124 Participants |
| Undetectable HIV viral load Last viral load was undetectable | 90 Participants | 78 Participants | 97 Participants | 265 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 130 | 0 / 130 |
| other Total, other adverse events | 0 / 129 | 0 / 130 | 0 / 130 |
| serious Total, serious adverse events | 0 / 129 | 0 / 130 | 0 / 130 |
Outcome results
Primary
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
Time frame: Month 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCC1--high Intensity Supervision | Number of Participants Who Used Dual Contraception or Safer Conception Method | 35 Participants |
| SCC2-- Low Intensity Supervision | Number of Participants Who Used Dual Contraception or Safer Conception Method | 19 Participants |
| Usual Care Family Planning Services | Number of Participants Who Used Dual Contraception or Safer Conception Method | 9 Participants |
95% CI: [2.79, 40.49]
Secondary
Number Who Achieved Desired Pregnancy Status
Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation
Time frame: Month 12
Population: Analysis conducted only among those trying to conceive (n=276)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCC1--high Intensity Supervision | Number Who Achieved Desired Pregnancy Status | 32 Participants |
| SCC2-- Low Intensity Supervision | Number Who Achieved Desired Pregnancy Status | 29 Participants |
| Usual Care Family Planning Services | Number Who Achieved Desired Pregnancy Status | 27 Participants |
95% CI: [0.25, 2.09]
Secondary
Partner HIV Status
Partner HIV status as determined by HIV antibody test conducted by study
Time frame: 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SCC1--high Intensity Supervision | Partner HIV Status | Number who tested HIV-positive | 0 Participants |
| SCC1--high Intensity Supervision | Partner HIV Status | Number who tested HIV-negative | 129 Participants |
| SCC2-- Low Intensity Supervision | Partner HIV Status | Number who tested HIV-positive | 1 Participants |
| SCC2-- Low Intensity Supervision | Partner HIV Status | Number who tested HIV-negative | 129 Participants |
| Usual Care Family Planning Services | Partner HIV Status | Number who tested HIV-negative | 130 Participants |
| Usual Care Family Planning Services | Partner HIV Status | Number who tested HIV-positive | 0 Participants |
95% CI: [0.02, 257.6]
Other Pre-specified
Cost-effectiveness of Safer Conception Counseling Intervention
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.
Time frame: 30 months of intervention implementation
Population: The primary analyses followed an intent-to-treat (ITT) approach. Cost-effectiveness data were not collected for the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCC1--high Intensity Supervision | Cost-effectiveness of Safer Conception Counseling Intervention | 520 US dollars | Standard Deviation 78 |
| SCC2-- Low Intensity Supervision | Cost-effectiveness of Safer Conception Counseling Intervention | 1014 US dollars | Standard Deviation 152 |