Letter to the Editor Response: Exploring COVID-19 Vaccine Hesitancy Among Stakeholders in African American and Latinx Communities in the Deep South Through the Lens of the Health Belief Model.

The purpose of this submission to respond to a Letter to the Editor recently submitted regarding our manuscript, "Exploring COVID-19 Vaccine Hesitancy among Stakeholders in African American and Latinx Communities in the Deep South through the Lens of the Health Belief Model" published in the American Journal of Health Promotion in February, 2022. The manuscript reported on a study that had as its purpose to qualitatively explore perceptions related to COVID-19 vaccination intention among African American and Latinx participants and suggest potential intervention strategies.

Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya.

OBJECTIVE: Home-based couples HIV testing and counseling and HIV self-testing (HIVST) for pregnant women can promote HIV status disclosure and male partner testing; however, cost data are lacking. We examined a home-based couples intervention (HBCI) and HIVST intervention costs per couple (unit cost) during pregnancy and postpartum in Kenya. METHODS: This randomized controlled trial is comparing HBCI and HIVST for couples among pregnant women attending antenatal care clinics in two counties in southwestern Kenya. We used micro-costing to estimate the unit cost per couple receiving the intervention as the total of direct and indirect costs for each study arm in 2019 US$. We used a one-month window to conduct a time and motion study to determine personnel effort and resources. We then compared the unit cost by arm, identified key cost drivers, and conducted sensitivity analyses for cost uncertainties. RESULTS: At base-case, the unit cost was $129.01 and $41.99, respectively, for HBCI and HIVST. Personnel comprised half of the unit cost for both arms. Staff spent more time on activities related to participant engagement in HBCI (accounting for 6.4% of the unit cost) than in HIVST (2.3%). Staff training was another key cost driver in HBCI (20.1% of the unit cost compared to 12.5% in HIVST). Sensitivity analyses revealed that the unit cost ranges were $104.64-$154.54 for HBCI and $30.49-$56.59 for HIVST. CONCLUSIONS: Our findings may guide spending decisions for future HIV prevention and treatment programs for pregnant couples in resource-limited settings such as Kenya.

Couple Efficacy and Communal Coping for HIV Prevention Among Kenyan Pregnant Couples.

Involving both partners of a couple in HIV prevention can improve maternal and child health outcomes in sub-Saharan Africa. Using data from 96 couples, we explored the actor and partner effects of perceived relationship dynamics on a couple's confidence and ability to reduce HIV risk together. Perceived relationship quality altered perceived confidence and ability to reduce HIV threat. One's own ability to confidently act together with their spouse appeared to be stronger for husbands than wives with respect to relationship commitment. A partner's confidence to communicate with their spouse about HIV risk reduction appeared to be stronger from husbands to wives for relationship satisfaction and trust. Gender differences in perceived relationship quality and effects on communal coping may exist and requires further study for applicability in intervention development in this setting. Efficacious couple-oriented interventions for HIV prevention should incorporate evidence on how partners mutually influence each other's health beliefs and behaviors.

Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial).

INTRODUCTION: Retention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced-based behavioural interventions on postpartum adherence and retention in WLWH in Kenya. METHODS: The Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster-randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty-four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text-messaging, (3) community-based mentor mothers (cMM) or (4) text-messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per-protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions. RESULTS: We enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost-to-follow-up (LTFU) and 95 (7.1%) were discontinued from the study. In intention-to-treat analyses, the relative risk of being retained at 12-months postpartum was not significantly higher in the intervention arms versus the control arm. In time-to-event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per-protocol analysis, the relative risk of 12-month postpartum retention was 24-29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16-1.32, p<0.001), cMM only RR 1.29 (95% CI 1.21-1.37, p<0.001) and cMM plus text RR 1.29 (1.21-1.37, p<0.001). Women LTFU were younger (p<0.001), less likely to be married (p<0.001) and more likely to be newly diagnosed with HIV during pregnancy (p<0.001). Self-reported ART adherence did not vary by study arm. CONCLUSIONS: Behavioural interventions using peer support and text messages did not appear to improve 12-month postpartum retention and adherence in intention-to-treat analyses. Higher levels of exposure to the interventions may be necessary to achieve the desired effects.

Exploring COVID-19 Vaccine Hesitancy Among Stakeholders in African American and Latinx Communities in the Deep South Through the Lens of the Health Belief Model.

PURPOSE: The purpose of this study was to qualitatively explore perceptions related to COVID-19 vaccination intention among African American and Latinx participants and suggest intervention strategies. APPROACH: Ninety minute virtual focus groups (N = 8), segmented by county, race and ethnicity were conducted with stakeholders from 3 vulnerable Alabama counties. PARTICIPANTS: Participants (N = 67) were primarily African American and Latinx, at least 19 years, and residents or stakeholders in Jefferson, Mobile, and Dallas counties. SETTING: Focus groups took place virtually over Zoom. METHODS: The semi-structured guide explored perceptions of COVID-19, with an emphasis on barriers and facilitators to vaccine uptake. Focus groups lasted approximately 90 minutes and were audio recorded, transcribed, and analyzed by a team of 3 investigators, according to the guidelines of Thematic Analysis using NVivo 12. To provide guidance in the development of interventions to decrease vaccine hesitancy, we examined how themes fit with the constructs of the Health Belief Model. RESULTS: We found that primary themes driving COVID-19 vaccine hesitancy, ordered from most to least discussed, are mistrust, fear, and lack of information. Additionally, interventions to decrease vaccine hesitancy should be multi-modal, community engaged, and provide consistent, comprehensive messages delivered by trusted sources.

Tenofovir Diphosphate in Dried Blood Spots in Pregnant and Postpartum Women With HIV in Kenya: A Novel Approach to Measuring Peripartum Adherence.

BACKGROUND: Adherence to antiretroviral therapy (ART) among pregnant and postpartum women with HIV (PWLWH) is critical to promote maternal health and prevent HIV transmission. Tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) is an objective assessment of cumulative ART adherence that has not been fully assessed in PWLWH. SETTING: Southwestern Kenya. METHODS: PWLWH receiving tenofovir disoproxil fumarate-based ART from 24 health facilities provided DBS samples at 3 time points [pregnancy/early postpartum (PP), 6 months PP, and 9-12 months PP]. Thresholds for daily adherence were defined as TFV-DP in DBS ≥650 fmol/punch in pregnancy and ≥950 PP. Descriptive analysis is presented. Cluster adjusted χ2 and t-tests were used to test for association with clinical and demographic factors. RESULTS: A total of 419 DBS samples were collected from 150 PWLWH. Median TFV-DP in DBS was lowest, 552 fmol/punch [interquartile range (IQR), 395-759] in pregnancy and declined over time [914 (IQR, 644-1176) fmol/punch; early PP; 838 (IQR, 613-1063) fmol/punch 6 months PP; and 785 (IQR, 510-1009) fmol/punch 9-12 months; P < 0.001]. Only 42% of samples in pregnancy and 38.5% of samples in PP met thresholds for daily adherence. Clinical or demographic factors were not associated with suboptimal adherence levels. CONCLUSION: Cumulative ART exposure in PWLWH, quantified by TFV-DP in DBS, demonstrated a stepwise decrease (ie, adherence) PP. Most women demonstrated less than daily adherence throughout the peripartum period. Use of TFV-DP in DBS as a measure of cumulative ART adherence could help optimize health outcomes in PWLWH and their infants.

Alcohol reduction outcomes following brief counseling among adults with HIV in Zambia: A sequential mixed methods study.

Data from sub-Saharan Africa on the impact of alcohol on the HIV epidemic in sub-Saharan Africa is limited. In this region, it is not well understood how people with HIV (PLWHA) respond to alcohol reduction counseling while they are linked to HIV clinical care. We conducted an explanatory sequential mixed-methods study to understand patterns of alcohol use among adults (18+ years) within a prospective HIV cohort at two urban public-sector clinics in Zambia. At antiretroviral therapy (ART) start and one year later, we measured alcohol use with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and those reporting any alcohol use were provided brief counseling. We conducted focus groups at 1 year with participants who had any alcohol use and 20 in-depth interviews among the subgroup with unhealthy use pre-ART and who either reduced or did not reduce their use by 1 year to moderate levels or abstinence. Focus group Discussions (FGDs) (n = 2) were also held with HIV clinic staff. Qualitative data were analyzed using thematic analysis. The data obtained from 693 participants was analyzed (median age 34 years, 45% men), it revealed that unhealthy alcohol use (AUDIT-C >3 for men; >2 for women) was reported among 280 (40.4%) at baseline and 205 (29.6%) at 1 year on ART. Reduction from unhealthy to moderate use or abstinence was more common with older age, female, non-smoking, and at Clinic B (all P<0.05). Qualitative data revealed ineffective alcohol support at clinics, social pressures in the community to consume alcohol, and unaddressed drivers of alcohol use including poverty, poor health status, depression, and HIV stigma. Healthcare workers reported a lack of training in alcohol screening and treatment, which led to mixed messages provided to patients ('reduce to safe levels' versus 'abstain'). In summary, interventions to reduce unhealthy alcohol use are needed within HIV clinics in Zambia as a substantial population have persistent unhealthy use despite current HIV clinical care. A better understanding is needed regarding the implementation challenges related to screening for unhealthy alcohol use integrated with HIV services.

Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study.

INTRODUCTION: Community-based mentor mothers (cMMs) are women living with HIV who provide peer support to pregnant/postpartum women living with HIV (PWLWH) to enhance antiretroviral therapy (ART) adherence, retention in care and prevent perinatal transmission of HIV. The goal of this study was to explore the experiences, perceptions, mechanisms and health impact of cMMs on PWLWH in Kenya from the perspective of cMMs. METHODS: We conducted a prospective mixed-methods study in southwestern Kenya in 2015-2018. In the qualitative phase, we completed in-depth interviews with cMMs to explore their perceptions and experiences in supporting PWLWH. Transcripts were broad-coded according to identified themes, then fine-coded using an inductive approach. In the quantitative phase, we analysed medical record data from PWLWH who were randomized in the cMM intervention to examine the impact of cMM visits on optimal prevention of mother-to-child transmission (PMTCT). We used cluster-adjusted generalized estimating equation models to examine relationships with a composite outcome (facility delivery, infant HIV testing, ART adherence and undetectable viral load at 6 weeks postpartum). Finally, qualitative and quantitative results were integrated. RESULTS: Convergence of findings from cMM interviews (n = 24) and PWLWH medical data (n = 589) revealed: (1) The cMM intervention was utilized and perceived as acceptable. PWLWH received, on average, 6.2 of 8 intended home visits through 6 weeks postpartum. (2) The cMMs reported serving as role models and confidantes, supporting PWLWH's acceptance of their HIV status, providing assurances about PMTCT and assisting with male partner disclosure and communication. cMMs also described benefits for themselves, including empowerment and increased income. (3) The cMM visits supported PWLWH's completion of PMTCT steps. Having ≥4 cMM home visits up to 6 weeks postpartum, as compared to <4 visits, was associated with higher likelihood of an optimal PMTCT composite outcome (adjusted relative risk 1.42, p = 0.044). CONCLUSIONS: We found that peer support from cMMs during pregnancy through 6 weeks postpartum was associated with improved uptake of critical PMTCT services and health behaviours and was perceived as beneficial for cMMs themselves. CMM support of PWLWH may be valuable for other low-resource settings to improve engagement with lifelong ART and HIV services among PWLWH.

Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial.

BACKGROUND: HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora ("Better Family" in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples' HIV testing and counseling services to improve family health. METHODS: This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples' HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. DISCUSSION: The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018.

Effects of a Home-Based Intervention on HIV Prevention Health Behaviors in Pregnant/Postpartum Kenyan Women: Estimating Moderating Effects of Depressive Symptoms.

We estimated effects of maternal depressive symptoms, utilizing the Patient Health Questionnaire-8 (PHQ-8), on women's HIV prevention behaviors in Migori County, Kenya. Pregnant women ≥ 18 years old, with gestational age of < 37 weeks, were randomized into standard care or three home visits (2 during pregnancy, 1 postpartum) promoting couple HIV testing and counseling (CHTC) and HIV prevention. Of 105 female participants, 37 (35.24%) reported depressive symptoms and 50 (47.62%) were HIV-positive. Three Poisson regressions with robust variance (univariable, multivariable, and multivariable with depressive symptoms/study arm interaction) were modeled for three outcomes: CHTC, infant HIV testing, health-seeking postpartum. In multivariable analysis with interaction, a moderating trend for the interaction between depressive symptoms and individual health-seeking was observed (p-value = 0.067). Women scoring ≤ 9 (n = 68) on the PHQ-8 and participating in home visits were 1.76 times more likely to participate in individual health-seeking compared to participants in standard care (ARR 1.76, 95% CI 1.17-2.66).

Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya.

BACKGROUND: Antiretroviral therapy (ART) is essential for the elimination of mother-to-child transmission and improved health outcomes for women living with HIV (WLWH). However, adverse pregnancy outcomes (APOs) among pregnant women on ART are a growing concern. METHODS: We investigated the associations between timing of ART initiation and APOs among pregnant WLWH receiving behavioral interventions (community mentor mothers and text messaging) in the Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study in southwestern Kenya. Log binomial models were used for estimation of relative risks (RRs) (adjusted for the clustered nature of data) evaluating APOs with 3 exposure comparisons: (1) preconception ART initiation vs. postconception initiation; (2) among postconception ART initiating women, comparisons across gestational ages at cART initiation (first versus second and third trimester exposure), and (3) intervention allocation. RESULTS: Of the 1275 women included in this analysis, 388 (30%) had an APO: 306 preterm births, 38 low birth weight infants, 33 stillbirths, and 11 miscarriages. In multivariable analysis, viral load ≥1000 copies/mL, moderate and severe anemia at baseline increased risk of APOs. Among women initiating ART before and after conception, no difference was observed in the composite APO. Women who received community mentor mother visits alone (aRR 0.74: 95% CI: 0.71 to 0.76) or text messages alone (aRR 0.79: 95% CI: 0.70 to 0.89) had lower risks of experiencing any APOs. CONCLUSIONS: Receiving supportive behavioral interventions may mitigate the risk of experiencing an APO among WLWH on ART. Further studies are needed to investigate the underlying mechanisms and optimize the benefits of these interventions.

Male partner involvement and successful completion of the prevention of mother-to-child transmission continuum of care in Kenya.

OBJECTIVE: To examine the relationship between male partner involvement (MPI) in prevention of mother-to-child transmission (PMTCT) activities and successful completion of the PMTCT continuum of care, which remains sub-optimal in settings with high prevalence of HIV. METHODS: A cross-sectional survey was administered in June-August 2017 to a sample of 200 postpartum Kenyan women with HIV enrolled in a parent trial. Composite PMTCT and MPI variables were created. Descriptive, simple and multivariable regression, and mediation analyses were performed. RESULTS: Of the women, 54% reported successful completion of PMTCT. Depression and internalized HIV stigma were independently associated with lower likelihood of successful completion of PMTCT (adjusted risk ratio [aRR] 0.97; 95% confidence interval [CI] 0.94-0.99; aRR 0.92; 95% CI 0.88-0.98, respectively). Each MPI activity was associated with 10% greater likelihood of successful completion of PMTCT (P < 0.05). The relationship between MPI and the successful completion of PMTCT was partially mediated through women's reduced internalized HIV stigma (ß -0.03; 95%CI -0.06 to -0.00). CONCLUSION: Greater MPI in PMTCT activities has direct and indirect effects on women's successful completion of all necessary steps across the PMTCT continuum. Reduced internalized HIV stigma is likely a key mechanism in the relationship.

Pathways for HIV Prevention Behaviors Following a Home-Based Couples Intervention for Pregnant Women and Male Partners in Kenya.

Pregnancy is a time of heightened HIV risk, but also a phase when a couple can prioritize family health. We conducted secondary analysis of a home-based intervention in rural Kenya to explore couple-level adherence to HIV prevention behaviors. The intervention included health education, relationship-building skills, and Couples HIV Testing and Counseling. Pregnant women were randomized to the intervention (n = 64) or standard care (n = 63) along with male partners. Of 96 couples, 82 (85.0%) were followed to 3 months postpartum, when 31.0% of couples reported perfect adherence to HIV prevention. In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32). A structural equation model found the intervention had moderate effects on couple communication, large effects on couple efficacy to take action around HIV, which in turn improved HIV prevention behaviors (CFI = 0.969; TLI = 0.955; RMSEA = 0.049). Strengthening couple communication and efficacy may help prevent the spread of HIV to infants or partners around the time of pregnancy.

HIV status disclosure patterns and male partner reactions among pregnant women with HIV on lifelong ART in Western Kenya.

Disclosure of HIV status to sexual partners in the context of prevention of mother-to-child transmission (PMTCT) may contribute to improved PMTCT outcomes. We administered a questionnaire to 200 women with HIV enrolled in a PMTCT study during pregnancy at 12 months after birth in Western Kenya between May-September 2017. Descriptive analysis of disclosure patterns and multivariate analysis of factors associated with male partner reactions is presented. Among 180 (90%) women who reported having a male partner, 95.5% reported disclosing their HIV status to that partner. The majority of women (82.8%) reported disclosure occurred within one year of their diagnosis, with 62.7% occurring within one week. The most common forms of disclosure were: self-disclosure (55.4%), during couple's HIV testing and counseling (CHTC) (31.5%), or at an antenatal care visit (7.7%). Most women (87.5%) reported that male partner reactions to their HIV status disclosure were positive. Those with negative reactions reported their partners were confused, annoyed, or threatened to leave, however there were no reports of intimate partner violence (IPV) or break ups. Disclosure via CHTC was associated with a positive male partner reaction compared to self-disclosure (adjusted OR (aOR) 20.2, 95% Confidence Interval (CI) 1.8-221.4). Those in concordant HIV status partnerships were more likely to have a positive reaction (aOR. 6.7, 95% CI 1.7-26.6). Women experiencing frequent verbal IPV were less likely to report a positive response (aOR 0.21, 95%CI 0.1-0.8). Most postpartum women with HIV in this cohort had disclosed to their male partners early after diagnosis and experienced a positive reaction. However, a minority had still not disclosed by 12 months after the birth and some experienced negative reactions to disclosure. The form of status disclosure and impact of intimate partner violence should be given greater attention within the context of PMTCT.

Effects of Depression, Stigma and Intimate Partner Violence on Postpartum Women's Adherence and Engagement in HIV Care in Kenya.

We explored the association between HIV-related stigma and experiences of intimate partner violence (IPV) and depression with viral load suppression, and medication and visit adherence in postpartum women receiving lifelong antiretroviral therapy (ART) (N = 200). We administered a cross-sectional survey to 200 women with HIV at 12 months postpartum who were enrolled in the MOTIVATE trial. The MOTIVATE study is a cluster-randomized trial evaluating the impact of community mentor mothers and text messaging on PMTCT outcomes in southwestern Kenya. Simple and multivariable logistic regression analysis was performed in STATA. Women who experienced stigma or IPV were more likely to miss clinic visits (internalized stigma aOR 1.30 95%CI 1.03-1.64; anticipated stigma aOR 1.20 95%CI 1.04-1.42; IPV aOR 15.71 95%CI 1.47-167.80), report difficulty taking ART drugs (internalized stigma aOR 1.32 95%CI 1.10-1.58; anticipated stigma aOR 1.14 95%CI 1.01-1.30) and not taking medication as prescribed (IPV aOR 2.00 95%CI 1.05-3.74). Depression was additionally associated with decreased odds of viral load suppression (aOR 0.16 95%CI 0.04-0.76). There is need to develop tailored psychosocial interventions within PMTCT programs that appropriately address mental health, stigma, and violence.

Development of a Novel Scale to Measure Male Partner Involvement in the Prevention of Mother-to-Child Transmission of HIV in Kenya.

Male partner involvement is an important factor in prevention of mother-to-child transmission (PMTCT). Yet, poor conceptualization has hindered optimal assessment of male involvement. We created and evaluated a brief 10-item male partner involvement scale using principal components analysis and scree plots, Cronbach's alpha, and linear regression with survey data from postpartum women with HIV (n = 200) in Kenya. The scale had a two-factor structure: male encouragement/reminders and active participation. The overall scale and the encouragement/reminders sub-scale displayed strong internal reliability. In the multivariable models, the scales were positively associated with constructive relationship dynamics, HIV status disclosure, and couple HIV testing and counseling, and negatively associated with internalized HIV stigma. The encouragements/reminders sub-scale was also negatively associated with a new HIV diagnosis during pregnancy. This work furthers the conceptualization of male partner involvement in PMTCT and provides a valid measure to assess male involvement as a pathway to better PMTCT outcomes.

Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study.

BACKGROUND: Option B+ is a comprehensive antiretroviral treatment (ART) designed for HIV-infected pregnant/ postpartum women. However, barriers to implementing Option B+ and establishing long-term ART adherence while facilitating retention in prevention of mother to child transmission of HIV (PMTCT) services remain. Community-based mentor mothers (cMMs) who can provide home-based support for PMTCT services may address some of the barriers to successful adoption and retention in Option B+. Thus, we evaluated the acceptability of using cMMs as home-based support for PMTCT services. METHODS: Gender-matched in-depth interviews were conducted between September-November 2014 for HIV-infected pregnant/postpartum women and their male partners living in southwestern Kenya (n = 40); additionally, we conducted four focus groups involving 30 health workers (n = 70) within four health facilities. Audio-recordings were transcribed, translated, and then coded using a thematic analytical approach in which data were deductively and inductively coded with support from prior literature, identified themes within the interview guides, and emerging themes from the transcripts utilizing Dedoose software. RESULTS: Overall, the study results suggest high acceptability of cMMs among individual participants and health workers. Stigma reduction, improvement of utilization of health care services, as well as ART adherence were most frequently discussed potential benefits of cMMs. Participants pictured a cMM as someone acting as a role model and confidant, and who was over 30 years old. Many respondents raised concerns about breaches of confidentiality and inadvertent disclosure. Respondent suggestions to overcome these issues included the cMM working in different communities than where she lives and attending home-visits with no identifying clothing as an HIV-related health worker. CONCLUSIONS: The home-based cMM approach may be a beneficial and acceptable strategy for promoting ART adherence and retention within PMTCT services for pregnant/postpartum women living with HIV. Considering the risks of inadvertent disclosure of HIV-infected status and related negative consequences for pregnant/postpartum women living with HIV, similar cMM program designs may benefit from recognizing and addressing these risks. TRIAL REGISTRATION: The MOTIVATE! study was registered on July 7, 2015 at the ClinicalTrials.gov ( NCT02491177 ).

Hepatitis B virus contact disclosure and testing in Lusaka, Zambia: a mixed-methods study.

OBJECTIVES: The aim of this study was to estimate the frequency of disclosure to and testing of contacts of patients with hepatitis B virus (HBV) in Zambia. DESIGN: We used a convergent parallel mixed-method research design including a quantitative survey and focus group discussions with patients with HBV. SETTING: A university hospital in Lusaka, Zambia. PARTICIPANTS: 79 hepatitis B surface antigen (HBsAg)-positive, HIV-negative, adults (18+ years) receiving HBV care completed a quantitative survey and 32 also participated in a focus group discussion. OUTCOMES AND ANALYSIS: Contacts of patients with HBV were enumerated and patient-reported disclosure, contact testing and contact HBV test results were used to develop a testing cascade. Using multivariable logistic regression, we identified factors associated with disclosure of HBV status. In focus groups, we explored how index patient knowledge and awareness of their condition shaped perspectives on contact disclosure and testing. Focus groups coding and analysis followed a thematic analysis approach. RESULTS: Among 79 patients with HBV (median age 35 years; 26.6% women), the majority reported disclosure to ≥1 contact. According to the index patients' knowledge, of 776 contacts enumerated, 326 (42.1%) were disclosed to, 77 (9.9%) were tested, 67 (8.6%) received results and 8 (11.9%) were HBsAg-positive. Increased stigma score was associated with reduced disclosure. In focus groups, HBV awareness, knowledge and stigma emerged as barriers to disclosure and referral of contacts for testing. Association of HBV with HIV-related stigma was also reported as a strong barrier to contact disclosure and testing and to taking antivirals for HBV monoinfection. CONCLUSIONS: HBV contact disclosure and testing were feasible and yielded new diagnoses in Zambia. A better understanding of barriers to seeking HBV testing and treatment is needed to scale-up this important intervention in Africa. TRIALS REGISTRATION NUMBER: NCT03158818.

Development and Piloting of a Home-Based Couples Intervention During Pregnancy and Postpartum in Southwestern Kenya.

Engaging both partners of a pregnant couple can enhance prevention of mother-to-child transmission of HIV and promote family health. We developed and piloted an intervention to promote couple collaboration in health during pregnancy and postpartum in southwestern Kenya. We utilized formative data and stakeholder input to inform development of a home-based couples intervention. Next, we randomized pregnant women to intervention (n = 64) or standard care (n = 63) arms, subsequently contacting their male partners for enrollment. In the intervention arm, lay health workers conducted couple home visits, including health education, couple relationship and communication skills, and offers of couple HIV testing and counseling (CHTC) services. Follow-up questionnaires were conducted 3 months postpartum (n = 114 women, 86 men). Baseline characteristics and health behaviors were examined by study arm using t-tests, chi-square tests, and regression analyses. Of the 127 women randomized, 96 of their partners participated in the study. Of 52 enrolled couples in the intervention arm, 94% completed at least one couple home visit. Over 93% of participants receiving couple home visits were satisfied and no adverse social consequences were reported. At follow-up, intervention couples had a 2.78 relative risk of having participated in CHTC during the study period compared with standard care couples (95% confidence interval: 1.63-4.75), and significant associations were observed in other key perinatal health behaviors. This pilot study revealed that a home-based couples intervention for pregnant women and male partners is acceptable, feasible, and has the potential to enhance CHTC and perinatal health behaviors, leading to improved health outcomes.

Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial.

BACKGROUND: Successful completion and retention throughout the multi-step cascade of prevention of mother-to-child HIV transmission (PMTCT) remains difficult to achieve. The Mother and Infant Visit Adherence and Treatment Engagement study aims to evaluate the effect of mobile text messaging, community-based mentor mothers (cMMs), or both on increasing antiretroviral therapy (ART) adherence, retention in HIV care, maternal viral load suppression, and mother-to-child HIV transmission for mother-infant pairs receiving lifelong ART. METHODS/DESIGN: This study is a cluster randomized, 2 × 2 factorial, controlled trial. The trial will be undertaken in the western Kenyan counties of Migori, Kisumu, and Homa Bay. Study sites will be randomized into one of four groups: six sites will implement both text messaging and cMM, six sites will implement cMM only, six sites will implement text messaging only, and six sites will implement the existing standard of care. The primary analysis will be based on the intention-to-treat principle and will compare maternal ART adherence and maternal retention in care. DISCUSSION: This study will determine the impact of long-term (up to 12 months postpartum) text messaging and cMMs on retention in and adherence to ART among pregnant and breastfeeding women living with HIV in Kenya. It will address key gaps in our understanding of what interventions may successfully promote long-term retention in the PMTCT cascade of care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02491177 . Registered on 11 March 2015.