Trial Outcomes & Findings for Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia (NCT NCT04729413)
NCT ID: NCT04729413
Last Updated: 2026-04-29
Results Overview
Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
478 participants
Primary outcome timeframe
Month 6 postpartum
Results posted on
2026-04-29
Participant Flow
Recruitment occurred from December 2020 - January 2023 at a public district hospital in Lusaka, Zambia.
Unit of analysis: Couples
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
242 121
|
236 118
|
|
Overall Study
COMPLETED
|
166 83
|
172 86
|
|
Overall Study
NOT COMPLETED
|
76 38
|
64 32
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
66
|
58
|
|
Overall Study
Adverse Event
|
10
|
6
|
Baseline Characteristics
Some baseline data is missing from enrolled participants who did complete the baseline survey.
Baseline characteristics by cohort
| Measure |
Couples Counseling Intervention
n=242 Participants
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.
|
Control
n=236 Participants
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.
|
Total
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Female participants
|
30.0 years
STANDARD_DEVIATION 5.8 • n=121 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
31.3 years
STANDARD_DEVIATION 5.7 • n=118 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
30.7 years
STANDARD_DEVIATION 5.8 • n=239 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
|
Age, Continuous
Male participants
|
36.4 years
STANDARD_DEVIATION 7.9 • n=120 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
37.8 years
STANDARD_DEVIATION 7.9 • n=114 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
37.1 years
STANDARD_DEVIATION 7.9 • n=234 Participants • Some baseline data is missing from enrolled participants who did complete the baseline survey.
|
|
Sex: Female, Male
Female
|
121 Participants
n=242 Participants
|
118 Participants
n=236 Participants
|
239 Participants
n=478 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=242 Participants
|
118 Participants
n=236 Participants
|
239 Participants
n=478 Participants
|
|
Race/Ethnicity, Customized
African (Zambian) · Female participants
|
121 Participants
n=242 Participants
|
118 Participants
n=236 Participants
|
239 Participants
n=478 Participants
|
|
Race/Ethnicity, Customized
African (Zambian) · Male participants
|
121 Participants
n=242 Participants
|
118 Participants
n=236 Participants
|
239 Participants
n=478 Participants
|
|
Region of Enrollment
Zambia
|
242 participants
n=242 Participants
|
236 participants
n=236 Participants
|
478 participants
n=478 Participants
|
|
Number of Female Participants with Viral Suppression (<1,000 copies/ml)
|
112 Participants
n=118 Participants • Viral load was only measured for female participants. Baseline viral loads were missing on n=5 participants who are not included in analysis population.
|
111 Participants
n=116 Participants • Viral load was only measured for female participants. Baseline viral loads were missing on n=5 participants who are not included in analysis population.
|
223 Participants
n=234 Participants • Viral load was only measured for female participants. Baseline viral loads were missing on n=5 participants who are not included in analysis population.
|
PRIMARY outcome
Timeframe: Month 6 postpartumPopulation: Female participants with endline viral load data.
Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression.
Outcome measures
| Measure |
Couples Counseling Intervention
n=83 Participants
ouples 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.
|
Control
n=86 Participants
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.
|
|---|---|---|
|
Female Participants With Viral Suppression (<1,000 Copies/ml)
|
82 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Month 6 postpartumPopulation: Female participants who answered the question on ART adherence on the endline questionnaire.
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.
Outcome measures
| Measure |
Couples Counseling Intervention
n=83 Participants
ouples 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.
|
Control
n=86 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence
|
83 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Month 6 postpartumPopulation: Female participants with endline data.
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.
Outcome measures
| Measure |
Couples Counseling Intervention
n=83 Participants
ouples 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.
|
Control
n=86 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Exclusive Breastfeeding
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Month 6 postpartumPopulation: Female participants who answered question on endline questionnaire
Survey question: "Are you currently using any form of family planning?" (yes)
Outcome measures
| Measure |
Couples Counseling Intervention
n=83 Participants
ouples 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.
|
Control
n=86 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Postpartum Use of Family Planning
|
61 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Month 6 postpartumPopulation: Female participants who answered question on endline questionnaire
Survey question: "Has the baby been tested for HIV?" (yes)
Outcome measures
| Measure |
Couples Counseling Intervention
n=83 Participants
ouples 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.
|
Control
n=86 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Infant HIV Testing
|
83 Participants
|
86 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6 postpartumPopulation: Female participants with viral load data at midline.
Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression.
Outcome measures
| Measure |
Couples Counseling Intervention
n=85 Participants
ouples 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.
|
Control
n=78 Participants
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.
|
|---|---|---|
|
Female Participants With Viral Suppression (<1,000 Copies/mL)
|
84 Participants
|
76 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6 postpartumPopulation: Number of participants who answered the question on ART adherence on the midline questionnaire
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.
Outcome measures
| Measure |
Couples Counseling Intervention
n=85 Participants
ouples 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.
|
Control
n=81 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence
|
85 Participants
|
81 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6 postpartumPopulation: Female participants who answered question on midline questionnaire
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.
Outcome measures
| Measure |
Couples Counseling Intervention
n=85 Participants
ouples 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.
|
Control
n=81 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Exclusive Breastfeeding
|
83 Participants
|
78 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6 postpartumPopulation: Female participants who answered question on midline questionnaire
Survey question: "Are you currently using any form of family planning?" (yes)
Outcome measures
| Measure |
Couples Counseling Intervention
n=85 Participants
ouples 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.
|
Control
n=81 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Postpartum Use of Family Planning
|
23 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 6 postpartumPopulation: Female participants who answered question on midline questionnaire
Survey question: "Has the baby been tested for HIV?" (yes)
Outcome measures
| Measure |
Couples Counseling Intervention
n=85 Participants
ouples 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.
|
Control
n=81 Participants
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.
|
|---|---|---|
|
Female Participants With Self-reported Infant HIV Testing
|
80 Participants
|
79 Participants
|
Adverse Events
Couples Counseling Intervention
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Couples Counseling Intervention
n=242 participants at risk
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.
|
Control
n=236 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
1.7%
4/242 • Number of events 4 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
0.00%
0/236 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.41%
1/242 • Number of events 1 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
0.42%
1/236 • Number of events 1 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.00%
0/242 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
0.42%
1/236 • Number of events 1 • From enrollment during pregnancy up 6 months postpartum, approximately 15 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place