Human Immunodeficiency Virus
Conditions
Brief summary
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.
Detailed description
Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p\<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.
Interventions
BEHAVIORALHome visits
If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.
BEHAVIORALHIV Self-testing
Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.
Sponsors
Kenya Medical Research Institute
University of Michigan
University of Witwatersrand, South Africa
University of Pennsylvania
National Institute of Mental Health (NIMH)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women at 36 weeks of pregnancy or less * 15 years of age or older * Has been offered HIV testing at ANC * Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy. * Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older. * Not in an HIV-positive concordant relationship.
Exclusion criteria
* Greater than 36 weeks of pregnancy * Less than 15 years of age * Not currently in a stable relationship with a male partner * Does not currently live with male partner * Has not been offered HIV testing at ANC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum | up to 12 months postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only) | Up to 12 months postpartum | 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. |
| Number of New Discordant Couples (Intervention Arms Only) | Up to 12 months postpartum | Number of new HIV serodiscordant couples identified during observation period. |
| HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum | Up to 18 months postpartum | 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. |
| Women Who Utilized All 4 MCH Services up to 3 Months Postpartum | 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. |
| Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) | Up to 18 months postpartum | 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. |
| Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum | Up to 12 months postpartum | 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. |
| Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up | Up to 12 months postpartum | 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. |
| Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up) | Up to 12 months postpartum | 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. |
| HIV Re-testing | Up to 12 months postpartum | Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire. |
| Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum | Up to 12 months postpartum | 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. |
| Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up | Up to 12 months postpartum | 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. |
| Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum) | 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. |
| Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum) | Up to 12 months postpartum | Mean number of HIV care visits assessed for HIV-positive men from baseline up to 12 months postpartum. |
| Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up) | Up to 18 months postpartum | Viral Load \< 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records. |
| HIV-free Child Survival | 18 months after the birth | Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records. |
| Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum | Up to 18 months after birth | 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+. |
| Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up) | Up to 18 months after birth | 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. |
| Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up) | Up to 12 months postpartum | 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. |
Countries
Kenya
Participant flow
Recruitment details
In a three-arm randomized controlled trial in southwestern Kenya (2019-2024), we recruited women attending antenatal care, subsequently contacting the male partner.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Home Visits Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker. | 534 |
| 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. | 532 |
| 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). | 534 |
| Total | 1,600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 24 | 11 | 13 |
| Overall Study | Death | 0 | 1 | 5 |
| Overall Study | Lost to Follow-up | 80 | 84 | 116 |
| Overall Study | Partner discontinued due to the death of the female participant or adverse event | 24 | 12 | 18 |
Baseline characteristics
| Characteristic | Home Visits | Total | Standard Care | HIV Self-testing |
|---|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 21 Participants | 11 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 529 Participants | 1579 Participants | 523 Participants | 527 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 534 Participants | 1600 Participants | 534 Participants | 532 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Maternal HIV Viral Suppression (HIV-positive Women) | 117 Participants | 355 Participants | 114 Participants | 124 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) | 283 Couples who had ever tested for HIV (=Y) | 75 Couples who had ever tested for HIV (=Y) | 103 Couples who had ever tested for HIV (=Y) |
| Number of individuals who had ever tested individually for HIV prior to study enrollment | 526 Ever tested for HIV individually (=Y) | 1566 Ever tested for HIV individually (=Y) | 517 Ever tested for HIV individually (=Y) | 523 Ever tested for HIV individually (=Y) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 534 Participants | 1600 Participants | 534 Participants | 532 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 534 Participants | 1600 Participants | 534 Participants | 532 Participants |
| Sex: Female, Male Female | 267 Participants | 800 Participants | 267 Participants | 266 Participants |
| Sex: Female, Male Male | 267 Participants | 800 Participants | 267 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 534 | 1 / 532 | 5 / 534 |
| other Total, other adverse events | 11 / 534 | 21 / 532 | 12 / 534 |
| serious Total, serious adverse events | 24 / 534 | 11 / 532 | 13 / 534 |
Outcome results
Primary
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum | 106 Couples tested for HIV as a couple (=Y) |
| Standard Care | Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum | 26 Couples tested for HIV as a couple (=Y) |
Comparison: Home visits as compared to Standard Carep-value: <0.00195% CI: [2.88, 6.18]Chi-squared
Comparison: HIV Self-testing as compared to Standard Carep-value: <0.00195% CI: [2.5, 5.45]Chi-squared
Secondary
HIV-free Child Survival
Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.
Time frame: 18 months after the birth
Population: Infants with 18 month final HIV testing and survival outcome. No stillbirths or miscarriages included in denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Visits | HIV-free Child Survival | 130 Participants |
| HIV Self-testing | HIV-free Child Survival | 141 Participants |
| Standard Care | HIV-free Child Survival | 142 Participants |
p-value: 0.08795% CI: [0.86, 0.95]Log Rank
p-value: 0.08795% CI: [0.91, 0.98]Log Rank
p-value: 0.08795% CI: [0.93, 0.99]Log Rank
Secondary
HIV Re-testing
Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Visits | HIV Re-testing | 338 Participants |
| HIV Self-testing | HIV Re-testing | 367 Participants |
| Standard Care | HIV Re-testing | 258 Participants |
Comparison: Comparison of the Home Visit arm with Standard Carep-value: 0.00195% CI: [1.12, 1.31]Chi-squared
Comparison: Comparison of HIVST arm with Standard Care armp-value: 0.00195% CI: [1.17, 1.36]Chi-squared
Secondary
HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum
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.
Time frame: Up to 18 months postpartum
Population: HIV positive women retained up to 18-months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum | 31 HIV+ women w/all 3 PMTCT interventions |
| HIV Self-testing | HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum | 28 HIV+ women w/all 3 PMTCT interventions |
| Standard Care | HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum | 28 HIV+ women w/all 3 PMTCT interventions |
Secondary
Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)
Viral Load \< 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Visits | Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up) | 117 Participants |
| HIV Self-testing | Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up) | 124 Participants |
| Standard Care | Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up) | 114 Participants |
Comparison: Comparison of the Home Visit arm with Standard Carep-value: 0.01195% CI: [1.03, 1.12]Chi-squared
Comparison: Comparison of the HIVST arm with Standard Carep-value: 0.01195% CI: [0.97, 1.08]Chi-squared
Secondary
Mean Man's Adherence to HIV Treatment (ART) (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.
Time frame: Up to 12 months postpartum
Population: HIV-positive men retained up to 12 months postpartum.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visits | 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 |
| HIV Self-testing | Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum) | 66 Adherence score | Standard Deviation 7.9 |
| Standard Care | Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum) | 65 Adherence score | Standard Deviation 8.2 |
Secondary
Mean Number of HIV Care Visits (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.
Time frame: Up to 12 months postpartum
Population: HIV-positive men retained up to 12 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visits | Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum) | 3.2 Number of visits | Standard Deviation 1.2 |
| HIV Self-testing | Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum) | 2.4 Number of visits | Standard Deviation 0.7 |
| Standard Care | Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum) | 2.9 Number of visits | Standard Deviation 1.5 |
Secondary
Mean Number of HIV Care Visits (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.
Time frame: Up to 12 months postpartum
Population: HIV-positive women retained up to 12-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visits | 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 |
| HIV Self-testing | Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up) | 4.7 Number of visits | Standard Deviation 1.4 |
| Standard Care | 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 |
Secondary
Mean Woman's Adherence to HIV Treatment (ART) (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.
Time frame: Up to 12 months postpartum
Population: HIV-positive women retained up to 12-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home Visits | 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 |
| HIV Self-testing | Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up) | 71.8 Adherence score | Standard Deviation 7.4 |
| Standard Care | Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up) | 71.3 Adherence score | Standard Deviation 8.8 |
Secondary
Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up
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.
Time frame: 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')
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up | 6 Number of men retained in HIV care(=Y) |
| Standard Care | Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up | 17 Number of men retained in HIV care(=Y) |
Secondary
Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum | 1 Number of men linked to HIV care (=Y) |
Secondary
Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up
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.
Time frame: 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')
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up | 165 Number of women retained in HIV care(=Y) |
| Standard Care | Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up | 159 Number of women retained in HIV care(=Y) |
Secondary
Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum | 1 Number of women linked to HIV care(=Y) |
| Standard Care | Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum | 1 Number of women linked to HIV care(=Y) |
Secondary
Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum
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+.
Time frame: Up to 18 months after birth
Population: Number of infants of HIV-positive women retained up to 18-months follow-up (coded as 'Yes')
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum | 1 Infants of HIV+ mothers who tested HIV+ |
| HIV Self-testing | Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum | 1 Infants of HIV+ mothers who tested HIV+ |
| Standard Care | Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum | 0 Infants of HIV+ mothers who tested HIV+ |
Secondary
Number of New Discordant Couples (Intervention Arms Only)
Number of new HIV serodiscordant couples identified during observation period.
Time frame: Up to 12 months postpartum
Population: All non-discordant couples at baseline. Data were collected in intervention arms only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Visits | Number of New Discordant Couples (Intervention Arms Only) | 93 Participants |
| HIV Self-testing | Number of New Discordant Couples (Intervention Arms Only) | 35 Participants |
| Standard Care | Number of New Discordant Couples (Intervention Arms Only) | 0 Participants |
Secondary
Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | 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) |
| HIV Self-testing | Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only) | 2 No. of men with new HIV+ diagnoses (=Y) |
Secondary
Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative 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.
Time frame: Up to 18 months postpartum
Population: HIV negative participants at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Visits | Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) | 47 Participants |
| HIV Self-testing | Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) | 49 Participants |
| Standard Care | Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline) | 46 Participants |
Secondary
Time to First Infant HIV Test (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.
Time frame: Up to 18 months after birth
Population: Infants of HIV-positive women retained up to 18-months follow-up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home Visits | Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up) | 6.6 Weeks |
| HIV Self-testing | Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up) | 6.3 Weeks |
| Standard Care | Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up) | 6.3 Weeks |
Secondary
Women Who Utilized All 4 MCH Services 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.
Time frame: Up to 3 months postpartum
Population: Women retained up to 3 months postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Visits | Women Who Utilized All 4 MCH Services up to 3 Months Postpartum | 116 Women who utilized all 4 MCH services |
| HIV Self-testing | Women Who Utilized All 4 MCH Services up to 3 Months Postpartum | 103 Women who utilized all 4 MCH services |
| Standard Care | Women Who Utilized All 4 MCH Services up to 3 Months Postpartum | 91 Women who utilized all 4 MCH services |