Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R00MH116735-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with HIV in Lusaka, Zambia.
The central hypothesis of this study is that women living with HIV in heterosexual couples that have better relationship functioning and more social support will have greater odds of achieving optimal health during and after pregnancy. The study further hypothesizes that the couples-based intervention will improve interpersonal dynamics, such as communication, and in intrapersonal factors, such as women's mental health, which will mediate intervention effects on HIV care and treatment outcomes. The study will test the hypotheses through two specific aims: (1) compare service utilization and prevention of mother-to-child transmission (PMTCT) outcome indicators in two study conditions; and (2) establish the effect of the intervention on intra- and inter-personal mechanisms influencing outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Couples Counseling Intervention | Experimental | Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple. |
|
| Control | Sham Comparator | Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Couples Counseling | Behavioral | Psychoeducational counseling on relationships and maternal and child health in the context of HIV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Female Participants With Viral Suppression (<1,000 Copies/ml) | Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. | Month 6 postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence | Survey question: "In the last 30 days, on how many days did you miss at least one dose of any of your HIV medicines?" Continuous measurement from 0 days to 30 days. | Month 6 postpartum |
| Female Participants With Self-reported Exclusive Breastfeeding |
| Measure | Description | Time Frame |
|---|---|---|
| Female Participants With Viral Suppression (<1,000 Copies/mL) | Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. | Week 6 postpartum |
| Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Hampanda, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chipata Health Centre | Lusaka | Lusaka Province | Zambia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment occurred from December 2020 - January 2023 at a public district hospital in Lusaka, Zambia.
| ID | Title | Description |
|---|---|---|
| FG000 | Couples Counseling Intervention | Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple. Couples Counseling: Psychoeducational counseling on relationships and maternal and child health in the context of HIV. |
| FG001 | Control | Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons). Enhanced Standard of Care: Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Couples Counseling Intervention | Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple. Couples Counseling: Psychoeducational counseling on relationships and maternal and child health in the context of HIV. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Some baseline data is missing from enrolled participants who did complete the baseline survey. |
| 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 | Female Participants With Viral Suppression (<1,000 Copies/ml) | Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. | Female participants with endline viral load data. | Posted | Count of Participants | Participants | Month 6 postpartum |
|
From enrollment during pregnancy up 6 months postpartum, approximately 15 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Couples Counseling Intervention | Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple. Couples Counseling: Psychoeducational counseling on relationships and maternal and child health in the context of HIV. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Hampanda | University of Colorado | 303-724-2041 | KAREN.HAMPANDA@CUANSCHUTZ.EDU |
Not provided
| 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 | Sep 18, 2020 | Oct 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2020 | Oct 11, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Couples are randomized 1:1 to receive the intervention (couples counseling and health education) or control (enhanced standard of care) in parallel for the duration of the study
Not provided
Not provided
Not provided
Not provided
| Enhanced Standard of Care | Other | Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. |
|
|
Survey question: "How is the baby currently being fed?" Exclusive breastfeeding is defined as providing only breastmilk to the infant for the first 6 months of life. |
| Month 6 postpartum |
| Female Participants With Self-reported Postpartum Use of Family Planning | Survey question: "Are you currently using any form of family planning?" (yes) | Month 6 postpartum |
| Female Participants With Self-reported Infant HIV Testing | Survey question: "Has the baby been tested for HIV?" (yes) | Month 6 postpartum |
Survey question: "In the last 30 days, on how many days did you miss at least one dose of any of your HIV medicines?" Continuous measurement from 0 days to 30 days. |
| Week 6 postpartum |
| Female Participants With Self-reported Exclusive Breastfeeding | Survey question: "How is the baby currently being fed?" Exclusive breastfeeding is defined as providing only breastmilk to the infant for the first 6 months of life. | Week 6 postpartum |
| Female Participants With Self-reported Postpartum Use of Family Planning | Survey question: "Are you currently using any form of family planning?" (yes) | Week 6 postpartum |
| Female Participants With Self-reported Infant HIV Testing | Survey question: "Has the baby been tested for HIV?" (yes) | Week 6 postpartum |
| BG001 | Control | Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons). Enhanced Standard of Care: Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Female Participants with Viral Suppression (<1,000 copies/ml) | Viral load was only measured for female participants. Baseline viral loads were missing on n=5 participants who are not included in analysis population. | Count of Participants | Participants |
|
| OG001 | Control | Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons). Enhanced Standard of Care: Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. |
|
|
|
| Secondary | Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence | Survey question: "In the last 30 days, on how many days did you miss at least one dose of any of your HIV medicines?" Continuous measurement from 0 days to 30 days. | Female participants who answered the question on ART adherence on the endline questionnaire. | Posted | Count of Participants | Participants | Month 6 postpartum |
|
|
|
| Secondary | Female Participants With Self-reported Exclusive Breastfeeding | Survey question: "How is the baby currently being fed?" Exclusive breastfeeding is defined as providing only breastmilk to the infant for the first 6 months of life. | Female participants with endline data. | Posted | Count of Participants | Participants | Month 6 postpartum |
|
|
|
|
| Secondary | Female Participants With Self-reported Postpartum Use of Family Planning | Survey question: "Are you currently using any form of family planning?" (yes) | Female participants who answered question on endline questionnaire | Posted | Count of Participants | Participants | Month 6 postpartum |
|
|
|
|
| Secondary | Female Participants With Self-reported Infant HIV Testing | Survey question: "Has the baby been tested for HIV?" (yes) | Female participants who answered question on endline questionnaire | Posted | Count of Participants | Participants | Month 6 postpartum |
|
|
|
| Other Pre-specified | Female Participants With Viral Suppression (<1,000 Copies/mL) | Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. | Female participants with viral load data at midline. | Posted | Count of Participants | Participants | Week 6 postpartum |
|
|
|
|
| Other Pre-specified | Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence | Survey question: "In the last 30 days, on how many days did you miss at least one dose of any of your HIV medicines?" Continuous measurement from 0 days to 30 days. | Number of participants who answered the question on ART adherence on the midline questionnaire | Posted | Count of Participants | Participants | Week 6 postpartum |
|
|
|
| Other Pre-specified | Female Participants With Self-reported Exclusive Breastfeeding | Survey question: "How is the baby currently being fed?" Exclusive breastfeeding is defined as providing only breastmilk to the infant for the first 6 months of life. | Female participants who answered question on midline questionnaire | Posted | Count of Participants | Participants | Week 6 postpartum |
|
|
|
|
| Other Pre-specified | Female Participants With Self-reported Postpartum Use of Family Planning | Survey question: "Are you currently using any form of family planning?" (yes) | Female participants who answered question on midline questionnaire | Posted | Count of Participants | Participants | Week 6 postpartum |
|
|
|
|
| Other Pre-specified | Female Participants With Self-reported Infant HIV Testing | Survey question: "Has the baby been tested for HIV?" (yes) | Female participants who answered question on midline questionnaire | Posted | Count of Participants | Participants | Week 6 postpartum |
|
|
|
|
| 0 |
| 242 |
| 5 |
| 242 |
| 0 |
| 242 |
| EG001 | Control | Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons). Enhanced Standard of Care: Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. | 1 | 236 | 2 | 236 | 0 | 236 |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |