Trial Outcomes & Findings for Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya (NCT NCT03547739)

Results Overview

Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1600 participants

Primary outcome timeframe

up to 12 months postpartum

Results posted on

2025-09-26

Participant Flow

In a three-arm randomized controlled trial in southwestern Kenya (2019-2024), we recruited women attending antenatal care, subsequently contacting the male partner.

A total of 800 pregnant couples (1,600 individuals) were randomized to the home visit intervention (HV, n=267 couples = 534 individuals), HIV self-test kits (HIVST, n=266 couples = 532 individuals), or standard care (SC, n=267 couples = 534 individuals).

Participant milestones

Participant milestones
Measure	Home Visits Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Overall Study STARTED	534	532	534
Overall Study COMPLETED	406	424	382
Overall Study NOT COMPLETED	128	108	152

Reasons for withdrawal

Reasons for withdrawal
Measure	Home Visits Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Overall Study Death	0	1	5
Overall Study Adverse Event	24	11	13
Overall Study Partner discontinued due to the death of the female participant or adverse event	24	12	18
Overall Study Lost to Follow-up	80	84	116

Baseline Characteristics

Participants numbers below represent number of couples who had ever tested for HIV as a couple prior to study enrollment (coded as 'Yes' value)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to 12 months postpartum

Population: Couple HIV Testing and Counseling was defined as testing together with partner at the clinic, home, or with HIV self-test kits at either 3 or 12 months postpartum. Couples with a test at 3 months postpartum only were considered tested.

Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.

Outcome measures

Outcome measures
Measure	Home Visits n=203 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=212 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=191 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum	114 Couples tested for HIV as a couple (=Y)	106 Couples tested for HIV as a couple (=Y)	26 Couples tested for HIV as a couple (=Y)

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: Individuals HIV Retesting and Counseling was defined as retesting at either 3 or 12 months postpartum after initial baseline testing. Individuals with a retest at 3 months postpartum only were considered to have retested at 12 months.

Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire.

Outcome measures

Outcome measures
Measure	Home Visits n=403 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=416 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=363 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
HIV Re-testing	338 Participants	367 Participants	258 Participants

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: HIV-negative Male Partners at baseline and retained at 12 months postpartum. Data were collected in intervention arms only.

Number of new HIV-positive test results of male partners from baseline to 12 months postpartum and coded as Y=those who had tested for HIV individually up to 12 months postpartum and N=those who had not tested for HIV individually up to 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=244 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=256 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)	9 No. of men with new HIV+ diagnoses (=Y)	2 No. of men with new HIV+ diagnoses (=Y)	—

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: All non-discordant couples at baseline. Data were collected in intervention arms only

Number of new HIV serodiscordant couples identified during observation period.

Outcome measures

Outcome measures
Measure	Home Visits n=94 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=98 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of New Discordant Couples (Intervention Arms Only)	93 Participants	35 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 18 months postpartum

Population: HIV positive women retained up to 18-months follow-up

Composite variable based on self-report data from women's questionnaires, coded as Y=those who were coded as Y on the three variables described below and N= those who were coded as N on one, two, or three variables described below: (1) mothers use of antiretrovirals (ARVs) (Y=those mothers who have used ARVs from baseline up to 18 months postpartum/N=those mothers who have not used ARVs at any time point between baseline up to 18 months postpartum), (2) prophylactic ARVs given to the infant (Y=those infants who were given prophylactic ARVs up to 18 months after the birth/N=those infants who were not given prophylactic ARVs at any point from birth up to 18 months after the birth), and (3) Y=if exclusive breastfeeding was practiced up to 6 months after the birth and N=if exclusive breastfeeding was not practiced up to 6 months after the birth.

Outcome measures

Outcome measures
Measure	Home Visits n=107 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=98 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=89 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum	31 HIV+ women w/all 3 PMTCT interventions	28 HIV+ women w/all 3 PMTCT interventions	28 HIV+ women w/all 3 PMTCT interventions

SECONDARY outcome

Timeframe: Up to 3 months postpartum

Population: Women retained up to 3 months postpartum

Composite variable based on self-report data from women's questionnaires: Y=if all described variables coded as Y, N=if at least one of the following variables coded as N: (1) Y=if a woman completed at least four antenatal care (ANC) visits during this pregnancy, N=if a woman completed less than four ANC visits during this pregnancy; (2) Y=if a childbirth was with a skilled attendant, N=if a childbirth was not with a skilled attendant; (3) Y=if a postpartum check-up was completed for a woman and N=if the women did not have a postpartum check-up, and (4) Y=if the infant had a postnatal check-up, N=if a if a postnatal check-up was not completed for the infant. These are assessed in the follow-up questionnaires completed up to 3 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=188 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=190 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=172 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Women Who Utilized All 4 MCH Services up to 3 Months Postpartum	116 Women who utilized all 4 MCH services	103 Women who utilized all 4 MCH services	91 Women who utilized all 4 MCH services

SECONDARY outcome

Timeframe: Up to 18 months postpartum

Population: HIV negative participants at baseline

Initiation of PrEP by participants with HIV-negative status at baseline, assessed at each follow-up in the questionnaires up to 18 months after the baby's birth.

Outcome measures

Outcome measures
Measure	Home Visits n=369 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=399 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=348 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline)	47 Participants	49 Participants	46 Participants

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: Number of HIV-positive women not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum (coded as "yes")

Number of HIV-positive women not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive woman at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=4 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=1 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=2 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum	4 Number of women linked to HIV care(=Y) Interval 0.0 to 0.0	1 Number of women linked to HIV care(=Y) Interval 0.0 to 22.9	1 Number of women linked to HIV care(=Y) Interval 0.0 to 3.3

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: Number of HIV-positive women at baseline retained in HIV care up to 12-months follow-up (coded as "Yes')

Woman's retention in HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive woman at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive woman at baseline has not been retained in HIV up to 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=151 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=165 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=160 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up	151 Number of women retained in HIV care(=Y)	165 Number of women retained in HIV care(=Y)	159 Number of women retained in HIV care(=Y)

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: HIV-positive women retained up to 12-months follow-up

Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job she was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each woman at each time point.

Outcome measures

Outcome measures
Measure	Home Visits n=151 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=165 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=160 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up)	73.9 Adherence score Standard Deviation 7.5	71.8 Adherence score Standard Deviation 7.4	71.3 Adherence score Standard Deviation 8.8

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: HIV-positive women retained up to 12-months follow-up

Mean number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records.

Outcome measures

Outcome measures
Measure	Home Visits n=151 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=165 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=160 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up)	4.7 Number of visits Standard Deviation 1.3	4.7 Number of visits Standard Deviation 1.4	4.7 Number of visits Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: Number of HIV-positive men not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum (coded as "yes")

Number of HIV-positive men not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum assessed at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline and not linked to HIV care at baseline reported being linked to HIV care at 12 months postpartum. Coded as N=if HIV-positive man at baseline and not linked to HIV care at baseline reported not being linked to HIV care at 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=2 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=1 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum	2 Number of men linked to HIV care (=Y)	1 Number of men linked to HIV care (=Y)	—

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: Number of HIV-positive men at baseline retained in HIV care up to 12-months follow-up (coded as "Yes')

Men's retention in HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Coded as Y=if HIV-positive man at baseline was retained in HIV care up to 12 months postpartum and N=if HIV-positive man at baseline has not been retained in HIV up to 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=14 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=6 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=17 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up	14 Number of men retained in HIV care(=Y)	6 Number of men retained in HIV care(=Y)	17 Number of men retained in HIV care(=Y)

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: HIV-positive men retained up to 12 months postpartum.

Mean self-reported adherence to ART assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum and confirmed through medical records. Mean self-reported adherence to ART was assessed using self-report questionnaire data for HIV-positive men at baseline and in the follow-up questionnaires completed up to 12 months postpartum. Adherence was measured using a 3-item adherence scale (Wilson et al., 2014) with items on number of missed doses, self-evaluation of how good a job he was doing with adherence, and how often taken as recommended; all for the last 30 days. An adherence score (possible range 0-100%) was calculated for each male partner at each time point using these three items.

Outcome measures

Outcome measures
Measure	Home Visits n=13 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=26 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=39 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum)	70.7 Adherence score Standard Deviation 7.9	66 Adherence score Standard Deviation 7.9	65 Adherence score Standard Deviation 8.2

SECONDARY outcome

Timeframe: Up to 12 months postpartum

Population: HIV-positive men retained up to 12 months postpartum

Mean number of HIV care visits assessed for HIV-positive men from baseline up to 12 months postpartum.

Outcome measures

Outcome measures
Measure	Home Visits n=13 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=26 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=39 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum)	3.2 Number of visits Standard Deviation 1.2	2.4 Number of visits Standard Deviation 0.7	2.9 Number of visits Standard Deviation 1.5

SECONDARY outcome

Timeframe: Up to 18 months postpartum

Population: Women living with HIV at initial baseline testing and retained at 18-month follow-up Viral load (VL) testing done in late pregnancy or 3 months, 12, and 18 months postpartum. Analysis included those with at least one follow up VL measurement

Viral Load \< 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.

Outcome measures

Outcome measures
Measure	Home Visits n=118 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=131 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=126 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)	117 Participants	124 Participants	114 Participants

SECONDARY outcome

Timeframe: 18 months after the birth

Population: Infants with 18 month final HIV testing and survival outcome. No stillbirths or miscarriages included in denominator.

Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.

Outcome measures

Outcome measures
Measure	Home Visits n=141 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=146 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=146 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
HIV-free Child Survival	130 Participants	141 Participants	142 Participants

SECONDARY outcome

Timeframe: Up to 18 months after birth

Population: Number of infants of HIV-positive women retained up to 18-months follow-up (coded as 'Yes')

Number of infants of HIV-positive mothers who tested HIV+ up to 18 months postpartum based on medical records. This is be a Y/N variable with Y if the infant tested HIV+ up to 18 months postpartum and N if they did not test HIV+.

Outcome measures

Outcome measures
Measure	Home Visits n=133 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=142 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=144 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum	1 Infants of HIV+ mothers who tested HIV+	1 Infants of HIV+ mothers who tested HIV+	0 Infants of HIV+ mothers who tested HIV+

SECONDARY outcome

Timeframe: Up to 18 months after birth

Population: Infants of HIV-positive women retained up to 18-months follow-up.

Time to first infant HIV test based on medical records. This is the number of weeks since the baby's birth to the first HIV test and is reported as a median weeks value for each study arm.

Outcome measures

Outcome measures
Measure	Home Visits n=141 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=146 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=146 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up)	6.6 Weeks Interval 6.0 to 10.0	6.3 Weeks Interval 6.0 to 8.6	6.3 Weeks Interval 6.0 to 8.2

Adverse Events

Home Visits

Serious events: 24 serious events

Other events: 11 other events

Deaths: 0 deaths

HIV Self-testing

Serious events: 11 serious events

Other events: 21 other events

Deaths: 1 deaths

Standard Care

Serious events: 13 serious events

Other events: 12 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Home Visits n=534 participants at risk Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=532 participants at risk Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=534 participants at risk Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Pregnancy, puerperium and perinatal conditions Miscarriage	0.37% 2/534 • Number of events 2 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/532 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.37% 2/534 • Number of events 2 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Pregnancy, puerperium and perinatal conditions Stillbirth	1.3% 7/534 • Number of events 7 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.56% 3/532 • Number of events 3 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	1.1% 6/534 • Number of events 6 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Pregnancy, puerperium and perinatal conditions Neonatal Deaths	2.1% 11/534 • Number of events 11 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/532 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.75% 4/534 • Number of events 4 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Pregnancy, puerperium and perinatal conditions Infant Deaths	0.56% 3/534 • Number of events 3 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.75% 4/532 • Number of events 4 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/534 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Pregnancy, puerperium and perinatal conditions Child death	0.19% 1/534 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/532 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.00% 0/534 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Pregnancy, puerperium and perinatal conditions Hospitalization	0.00% 0/534 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/532 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.00% 0/534 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.

Other adverse events

Other adverse events
Measure	Home Visits n=534 participants at risk Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=532 participants at risk Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=534 participants at risk Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).
Social circumstances Separation/relationship dissolution	0.37% 2/534 • Number of events 2 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	1.9% 10/532 • Number of events 10 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.37% 2/534 • Number of events 2 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Social circumstances New intimate partner violence	1.1% 6/534 • Number of events 6 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	1.9% 10/532 • Number of events 10 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	1.5% 8/534 • Number of events 8 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.
Psychiatric disorders Depression	0.56% 3/534 • Number of events 3 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.19% 1/532 • Number of events 1 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.	0.37% 2/534 • Number of events 2 • From enrollment until end of follow-up: up to 18 months postpartum Adverse events were self-reported, reported during regular follow-ups, or detected through data abstraction from medical records. Reporting followed standard operating procedures, guidance from ethical boards and funder, as well as the study Data Safety Monitoring Board process review and reporting. Couples who experienced adverse pregnancy outcomes were discontinued from the study as the intervention sessions focused on health during pregnancy and postpartum.

Additional Information

Janet M. Turan, PhD, MPH

University of Alabama at Birmingham

Phone: 2059757770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Home Visits n=534 Participants Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.	HIV Self-testing n=532 Participants Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.	Standard Care n=534 Participants Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).	Total n=1600 Participants Total of all reporting groups
Sex: Female, Male Female	267 Participants n=534 Participants	266 Participants n=532 Participants	267 Participants n=534 Participants	800 Participants n=1600 Participants
Sex: Female, Male Male	267 Participants n=534 Participants	266 Participants n=532 Participants	267 Participants n=534 Participants	800 Participants n=1600 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Race (NIH/OMB) Asian	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Race (NIH/OMB) Black or African American	534 Participants n=534 Participants	532 Participants n=532 Participants	534 Participants n=534 Participants	1600 Participants n=1600 Participants
Race (NIH/OMB) White	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Race (NIH/OMB) More than one race	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	534 Participants n=534 Participants	532 Participants n=532 Participants	534 Participants n=534 Participants	1600 Participants n=1600 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Region of Enrollment Kenya	534 Participants n=534 Participants	532 Participants n=532 Participants	534 Participants n=534 Participants	1600 Participants n=1600 Participants
Number of couples who had ever tested for HIV as a couple prior to study enrollment	105 Couples who had ever tested for HIV (=Y) n=266 Participants • Participants numbers below represent number of couples who had ever tested for HIV as a couple prior to study enrollment (coded as 'Yes' value)	103 Couples who had ever tested for HIV (=Y) n=262 Participants • Participants numbers below represent number of couples who had ever tested for HIV as a couple prior to study enrollment (coded as 'Yes' value)	75 Couples who had ever tested for HIV (=Y) n=262 Participants • Participants numbers below represent number of couples who had ever tested for HIV as a couple prior to study enrollment (coded as 'Yes' value)	283 Couples who had ever tested for HIV (=Y) n=790 Participants • Participants numbers below represent number of couples who had ever tested for HIV as a couple prior to study enrollment (coded as 'Yes' value)
Age, Categorical <=18 years	5 Participants n=534 Participants	5 Participants n=532 Participants	11 Participants n=534 Participants	21 Participants n=1600 Participants
Age, Categorical Between 18 and 65 years	529 Participants n=534 Participants	527 Participants n=532 Participants	523 Participants n=534 Participants	1579 Participants n=1600 Participants
Age, Categorical >=65 years	0 Participants n=534 Participants	0 Participants n=532 Participants	0 Participants n=534 Participants	0 Participants n=1600 Participants
Number of individuals who had ever tested individually for HIV prior to study enrollment	526 Ever tested for HIV individually (=Y) n=533 Participants • Number of individuals who had ever tested individually for HIV prior to study enrollment (coded as 'Yes')	523 Ever tested for HIV individually (=Y) n=529 Participants • Number of individuals who had ever tested individually for HIV prior to study enrollment (coded as 'Yes')	517 Ever tested for HIV individually (=Y) n=531 Participants • Number of individuals who had ever tested individually for HIV prior to study enrollment (coded as 'Yes')	1566 Ever tested for HIV individually (=Y) n=1593 Participants • Number of individuals who had ever tested individually for HIV prior to study enrollment (coded as 'Yes')
Maternal HIV Viral Suppression (HIV-positive Women)	117 Participants n=118 Participants • All HIV-positive women at baseline.	124 Participants n=131 Participants • All HIV-positive women at baseline.	114 Participants n=126 Participants • All HIV-positive women at baseline.	355 Participants n=375 Participants • All HIV-positive women at baseline.