Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

Background HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use. Methods Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation. Discussion This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting. Trial registration NCT05322629 : Date of registration: April 12, 2022

Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa

BackgroundAdolescent girls and young women (AGYW) in South Africa are at a higher risk of acquiring HIV. Despite the increasing availability of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention, knowledge on PrEP use during pregnancy and postpartum periods at antenatal care (ANC) facilities remains inadequate.MethodsData from HIV-uninfected pregnant women in Cape Town, South Africa, were used in this study. These women aged 16–24 years were enrolled in the PrEP in pregnancy and postpartum (PrEP-PP) cohort study during their first ANC visit. Using the PrEP cascade framework, the outcomes of the study were PrEP initiation (prescribed tenofovir disoproxil fumarate and emtricitabine at baseline), continuation (returned for prescription), and persistence [quantifiable tenofovir diphosphate (TFV-DP) in dried blood samples]. The two primary exposures of this study were risk perception for HIV and baseline HIV risk score (0–5), which comprised condomless sex, more than one sexual partner, partner living with HIV or with unknown serostatus, laboratory-confirmed sexually transmitted infections (STIs), and hazardous alcohol use before pregnancy (Alcohol Use Disorders Identification Test for Consumption score ≥ 3). Logistic regression was used to examine the association between HIV risk and PrEP, adjusting for a priori confounders.ResultsA total of 486 pregnant women were included in the study, of which 16% were “adolescents” (aged 16–18 years) and 84% were “young women” (aged 19–24 years). The adolescents initiated ANC later than the young women [median = 28 weeks (20–34) vs. 23 weeks (16–34), p = 0.04]. Approximately 41% of the AGYW were diagnosed with sexually transmitted infection at baseline. Overall, 83% of the AGYW initiated PrEP use during their first ANC. The percentage of PrEP continuation was 63% at 1 month, 54% at 3 months, and 39% at 6 months. Approximately 27% consistently continued PrEP use through 6 months, while 6% stopped and restarted on PrEP use at 6 months. With a higher risk score of HIV (≥2 vs. ≤1), the AGYW showed higher odds of PrEP continuation [adjusted odds ratio: 1.85 (95% CI: 1.12–3.03)] through 6 months, adjusting for potential confounders. Undergoing the postpartum period (vs. pregnant) and having lower sexual risk factors were found to be the barriers to PrEP continuation. TFV-DP concentration levels were detected among 49% of the AGYW, and 6% of these women had daily adherence to PrEP at 3 months.ConclusionsAGYW were found to have high oral PrEP initiation, but just over one-third of these women continued PrEP use through 6 months. Pregnant AGYW who had a higher risk of acquiring HIV (due to condomless sex, frequent sex, and STIs) were more likely to continue on PrEP use through the postpartum period. Pregnant and postpartum AGYW require counseling and other types of support, such as community delivery and peer support to improve their effective PrEP use through the postpartum period.Clinical Trial NumberClinicalTrials.gov, NCT03826199

Oral pre-exposure prophylaxis delivery among HIV-negative pregnant and postpartum women in antenatal clinics of Cape Town, South Africa: Adolescent Girls and Young Women, Intimate Partner Violence, and Prevention-effective Adherence

HIV acquisition risks remain high for pregnant and breastfeeding populations in South Africa. Oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) can be used daily during periods of sexual activity to prevent HIV infections for cisgender women. In 2021, oral PrEP became the standard of care for HIV prevention during pregnancy and breastfeeding periods. The objective of this dissertation was to evaluate trends in oral PrEP initiation, continuation, and adherence among adolescent girls and young women, women experiencing intimate partner violence, and by sexual behaviors throughout gestational periods and postpartum. We used data from the PrEP in Pregnancy and Postpartum (PrEP-PP) study, a prospective cohort in Cape Town of 1200 participants without HIV. The PrEP-PP study provided HIV prevention counselling and offered PrEP to pregnant and breastfeeding women.The first study evaluated the oral PrEP cascade framework among adolescent girls and young women (AGYW) in the PrEP-PP study. Approximately 83% of AGYW initiated PrEP at their first antenatal care (ANC) visit, 34% continued PrEP at 6 months, and 11% stopped and restarted. AGYW with a higher HIV risk had an increased adjusted likelihood of continuing PrEP through 6 months (adjusted odds ratio[aOR]:1.91 [95% CI, 1.15-3.16]). About 7% of AGYW had high adherence to PrEP at 6 months. The second study examined the relationship between recent and past-year intimate partner violence (IPV) experienced by pregnant and postpartum women and oral PrEP continuation and adherence. Women who experienced past-year IPV were less likely to discontinue PrEP(adjusted hazards ratio: 0.80 (95% CI: 0.61, 1.06) and had higher adherence(quantifiable tenofovir-diphosphate[TFV-DP] in dried blood spots; aOR=1.82 (95% CI: 1.02, 3.25) at 6-month follow-up visits. The third study evaluated prevention-effective adherence by gestational trimesters of pregnancy and postpartum. Prevention-effective adherence(initiation/quantifiable TFV-DP or reported use during follow-up among those engaging in condomless sex) was 65% overall, with the highest adherence in trimester 1(81%) and lowest at early postpartum(49%). There was a positive association between engaging in condomless sex and PrEP use(quantifiable TFV-DP or self-reported use; adjusted risk ratio:1.88; 95% CI: 1.67, 2.12). In conclusion, AGYW during pregnancy and postpartum had high oral uptake, but retention in PrEP by 6 months was low. Those with higher HIV risks are more likely to continue PrEP. Pregnant/postpartum women who experienced past-year IPV were more likely to stay in the study and had greater adherence. The findings suggest that pregnant and postpartum women align their PrEP use with their potential HIV risks. Implementing violence screening and oral PrEP counselling (with conversations about changing HIV risks) at ANC may improve HIV prevention for women during pregnancy and postpartum in South Africa and beyond

Associations between Child Snack and Beverage Consumption, Severe Dental Caries, and Malnutrition in Nepal

The global nutrition transition and increased consumption of sugar-sweetened beverages and ultra-processed snacks have contributed to increasing rates of child obesity and dental caries in developing countries. In Nepal, where child malnutrition rates are high, the relationship between malnutrition and dental caries is poorly understood. This cross-sectional study aims to assess this relationship among a convenience sample of 273 children age six months to less than 12 years in three communities in Nepal, using parent/caregiver interviews, child dental exams, and anthropometric measurements. Fisher’s exact test and independent t-tests examined associations between dietary practices and severe caries and between severe caries and malnutrition, respectively. Children consumed sugar-sweetened beverages and processed snacks frequently: 80% consumed tea with sugar, 60% consumed sweet snacks, and 65% consumed processed savory snacks daily. Overall, 74% of children had untreated tooth decay, and 21% exhibited stunting malnutrition, 14% were underweight, and 6% presented wasting. Significant associations were found between daily consumption of sweets and processed snacks with severe caries and between severe caries and poorer nutritional status. These findings underscore the need to incorporate nutrition and oral health promotion and dental treatment into maternal–child health services and schools and to strengthen policies to reduce children’s access to junk food

Early Childhood Junk Food Consumption, Severe Dental Caries, and Undernutrition: A Mixed-Methods Study from Mumbai, India

In India, globalization has caused a nutrition transition from home-cooked foods to processed sugary snacks and drinks, contributing to increased early childhood caries (ECC). This mixed-methods study describes risk factors for ECC and associations with undernutrition in low-income communities in Mumbai. Interviews with mothers of 959 children, ages six-months through six-years, addressed maternal-child nutrition and oral health, and children received dental exams and anthropometric assessments. Focus groups with community health workers and mothers explored experiences and perceptions of oral health, nutrition, and ECC. Descriptive and logistic regression analyses of quantitative data, and content analysis of qualitative data were performed. Eighty percent of children lived 5 min from a junk-food store, over 50% consumed junk-food and sugary tea daily, 50% experienced ECC, 19% had severe deep tooth decay, 27% experienced mouth pain, and 56% experienced chronic and/or acute malnutrition. In children ages 3–6, each additional tooth with deep decay was associated with increased odds of undernutrition (Odds Ratio [OR] 1.10, Confidence Interval [CI] 1.02–1.21). Focus groups identified the junk-food environment, busy family life, and limited dental care as contributors to ECC. Policy interventions include limits on junk-food marketing and incorporating oral health services and counseling on junk-food/sugary drinks into maternal–child health programs

Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa.

IntroductionPre-exposure prophylaxis (PrEP) is a safe and effective prevention strategy to reduce women's risk of HIV in pregnancy and postpartum. Effective PrEP protection requires daily PrEP adherence, but little is known about maternal PrEP continuation and factors that influence PrEP use.MethodsThe PrEP in pregnancy and postpartum (PrEP-PP) study enrolled consenting pregnant, HIV-negative women at first antenatal care (ANC) visit with follow-up through 12 months postpartum. Eligible and consenting women and girls ≥16 years received HIV prevention counselling and were offered PrEP. Interviewers collected socio-demographic and behavioural data from participants at each visit. We analysed the proportion of women who initiated PrEP and the proportion who continued PrEP after 3 months with associated correlates by estimating the prevalence ratio adjusting for a priori confounders.ResultsBetween August 2019 and October 2021, we enrolled 1201 pregnant women (median gestation 21 weeks; age 26 years); 84% of women initiated PrEP at their first ANC visit (n = 1014); 55% were married or cohabiting. Overall, 66% of women on PrEP returned for a repeat prescription at 1 month; 58% returned at 3 months (n = 493 of 844). Almost one-half of women on PrEP reported a side effect at 1 month, mostly nausea/vomiting. Women on PrEP in the first and second trimesters had higher odds of reporting side effects (aOR 2.61; 95% CI 1.17-5.84) versus postpartum women. Women who reported side effects continued with PrEP less than those who did not report side effects (aPR = 0.87; 95% CI 0.77-0.97). Women with ≥1 previous pregnancy (aPR = 0.76; 95% CI 0.57-1.01) or were postpartum (aPR 0.85; 95% CI 0.75-0.97) were less likely to continue PrEP compared to women who were primigravid or pregnant. Women who reported having an HIV+ partner (aPR = 1.45; 95% CI 1.13-1.85) or high HIV risk perception (aPR = 1.20, 95% CI = 1.01-1.41) were more likely to continue on PrEP than those who had HIV-negative partners or low risk perception.ConclusionsPrEP initiation and early continuation were high in this setting, compared to other studies in women. Being postpartum and experiencing side effects were associated with lower PrEP continuation, presenting opportunities for counselling on early transient side effects. Interventions for postpartum women on PrEP are needed

Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study

BackgroundIn South Africa, at least 7.5 million people (age ≥15 years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15 years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known.MethodsWe purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July-September 2020. We restricted our analysis to pregnant AGYW (age: 16-25 years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25 days in the past 30 days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5 days in the last 30 days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo-v.1.5.ResultsWe interviewed 18 AGYW (mean age = 22 years), at a mean of 14 weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners' (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation.ConclusionsPrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting

Early Childhood Oral Health and Nutrition in Urban and Rural Nepal

Globalization and urbanization in Nepal have driven a nutritional transition from an agricultural-based diet to an ultra-processed, sugary diet. This study assessed the nutrition and oral health of 836 children age 6 months to 6 years and their families in rural and urban Nepal. Mothers were interviewed about maternal–child oral health and nutrition, and children received dental exams and height and weight measurements. Analyses utilized SPSS statistical software. Most families lived within a 5-minute walk to a store selling ultra-processed snacks and sugary drinks. While most mothers knew sweets caused tooth decay, half of the children were given sweets daily, and 58.2% of children had dental caries. Caries began in the first 2 years and increased in prevalence and severity to age 6, when 74.3% had caries and 20% experienced mouth pain. Despite greater health knowledge and resources among urban mothers, urban children’s increased access to junk food and frequency of consumption was associated with higher prevalence and severity of caries compared to rural children. Severe caries was associated with malnutrition, especially in rural children. Preventive strategies are needed in early childhood to incorporate nutrition and oral health education and dental care into maternal–child health services, and develop policies to prohibit the sale of junk food around school

Early Childhood Oral Health and Nutrition in Urban and Rural Nepal

Globalization and urbanization in Nepal have driven a nutritional transition from an agricultural-based diet to an ultra-processed, sugary diet. This study assessed the nutrition and oral health of 836 children age 6 months to 6 years and their families in rural and urban Nepal. Mothers were interviewed about maternal–child oral health and nutrition, and children received dental exams and height and weight measurements. Analyses utilized SPSS statistical software. Most families lived within a 5-minute walk to a store selling ultra-processed snacks and sugary drinks. While most mothers knew sweets caused tooth decay, half of the children were given sweets daily, and 58.2% of children had dental caries. Caries began in the first 2 years and increased in prevalence and severity to age 6, when 74.3% had caries and 20% experienced mouth pain. Despite greater health knowledge and resources among urban mothers, urban children’s increased access to junk food and frequency of consumption was associated with higher prevalence and severity of caries compared to rural children. Severe caries was associated with malnutrition, especially in rural children. Preventive strategies are needed in early childhood to incorporate nutrition and oral health education and dental care into maternal–child health services, and develop policies to prohibit the sale of junk food around school