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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD090981 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Mercy Hospital Kansas City | OTHER |
| Makerere University | OTHER |
| The AIDS Support Organization | OTHER |
| University of Kansas |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCC1--high intensity supervision | Experimental | Integration of safer conception counseling into family planning services, with intensive training and supervision |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| safer conception counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number Who Achieved Desired Pregnancy Status | Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation | Month 12 |
| Partner HIV Status | Partner HIV status as determined by HIV antibody test conducted by study |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Wagner, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TASO | Mbale, Entebbe, Jinja, Masaka, Mbarara, Runkangiri | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33858462 | Derived | 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. | |
| 33468072 | Derived |
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A data sharing plan is in place to provide a de-identified dataset to researchers who request access or through an NIH-affiliated repository
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Count of Participants | Participants | Month 12 |
|
12 month study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glenn Wagner | RAND Corporation | 310-393-0411 | 7698 | gwagner@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Oct 27, 2022 | Prot_SAP_000.pdf |
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| OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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.
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|
| study end point (Month 12 or when learning of pregnancy) |
| 30 months of intervention implementation |
| 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. |
| 30107843 | Derived | 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. |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Currently on ART | Whether or not the participant was currently prescribed antiretroviral therapy (ART) at the time of the assessment was obtained via chart abstraction; this is a binary variable (counting those currently on ART) | Count of Participants | Participants |
|
| Undetectable HIV viral load | HIV viral load data was abstracted from clinic charts; this variable is binary and represents whether or not the participant's last viral load at the time of the assessment was undetectable (< 20 copies per cubic millimeter) or not. | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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 |
|
|
|
| Secondary | Number Who Achieved Desired Pregnancy Status | Number who achieved desired pregnancy status depending on what client chooses after safer conception consultation | Analysis conducted only among those trying to conceive (n=276) | Posted | Count of Participants | Participants | Month 12 |
|
|
|
|
| Secondary | Partner HIV Status | Partner HIV status as determined by HIV antibody test conducted by study | The primary analyses followed an intent-to-treat (ITT) approach (i.e., outcomes with missing data are designated as having negative outome) | Posted | Count of Participants | Participants | study end point (Month 12 or when learning of pregnancy) |
|
|
|
|
| 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. | The primary analyses followed an intent-to-treat (ITT) approach. Cost-effectiveness data were not collected for the usual care arm. | Posted | Mean | Standard Deviation | US dollars | 30 months of intervention implementation |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | 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. | 0 | 130 | 0 | 130 | 0 | 130 |
| EG002 | 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 | 0 | 130 | 0 | 130 | 0 | 130 |
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