Understanding how COVID-19 affected black pregnant women early in the pandemic: A cross-sectional survey.

OBJECTIVE: Previous research has shown that the COVID-19 pandemic significantly increased anxiety among pregnant women, and at the same time, COVID-19 has disproportionately affected communities of color in the United States. We sought to understand how self-identied Black pregnant women in the United States were affected in the early days of the COVID-19 pandemic. DESIGN: Cross-sectional, online survey distributed via social media SETTING: Online PARTICIPANTS: Non-probability, convenience sample of self-identified Black pregnant women in the United States between April 3 and 24, 2020 who responded to an online inquiry seeking women who were pregnant at the outset of the COVID-19 pandemic. MEASUREMENTS AND FINDINGS: An anonymous, self-administered, online survey of pregnant women was conducted, including both quantitative assessment of demographics, COVID-related anxiety, and pregnancy-related anxiety as well as open-ended prompts for qualitative assessment of the impact of COVID on prenatal care, birth plans, anxiety and overall experience of pregnancy. Quantitative data were analyzed using Stata 15.0, qualitative data were thematically analyzed using NVivo12.1. Results were compared using joint display methodology. Of 87 self-identified Black or African-American women who responded, the most common concerns related to fear of getting infected with COVID (89.7 %, N = 78) and concerns related to loss of job/income (67.8 %, N = 59). More than half (55.2 %, N = 48) reported either themselves or their family members working in essential services. Findings indicate that uncertainty, lack of support, perceived quality of care, and heightened anxiety worked together to define Black women's experiences of pregnancy in the early days of the COVID-19 pandemic in the U.S. While quantitative data did not explicitly capture reports of discrimination as impacting perceived quality of care, the qualitative data suggest a link between fears of discrimination, the need for self-advocacy, and heightened anxiety. KEY CONCLUSIONS: Despite being a relatively well-educated sample of Black women from around the United States, many respondents spoke of the fears of discrimination, the need for self-advocacy, and heightened anxiety, reinforcing that discrimination and fear of discrimation for Black women in healthcare settings are pervasive, regardless of a woman's level of education or other socioeconomic status indicators. IMPLICATIONS FOR PRACTICE: These findings suggest that in times of uncertainty, such as the early days of the COVID-19 pandemic, it is more important than ever to provide thoughtful, supportive care to pregnant women of color who are primed for negative experiences in the healthcare settting.

Elevating Women's Voices: The Illinois Maternal Health Digital Storytelling Project.

Numerous initiatives at the national, state, and local levels are focused on addressing the U.S. maternal health crisis. However, most efforts fail to center women's voices and personal perspectives about pregnancy experiences and complications. This article describes the Illinois Maternal Health Digital Storytelling Project conducted by the University of Illinois at Chicago, in partnership with StoryCenter, a storytelling nonprofit organization based in Berkeley, California. The project aimed to elevate voices (stories) to complement other sources of data on maternal outcomes. We relied on partners to help recruit storytellers with a self-identified perinatal-related challenge. We screened interested individuals using a trauma-informed approach and a social worker provided storytellers with support during the project. Two groups participated in this project, one in 2021 and another in 2022, culminating with 10 digital stories. Both instances were conducted virtually and included group and individual skills-based sessions where storytellers learned to create and edit their digital stories. The storytellers own their digital stories and provided consent to include them in ongoing dissemination efforts. In September 2021, a webpage was launched to house the stories, and this resource is being shared widely. Evaluation efforts of the webpage are ongoing to understand how these digital stories are being used to inform maternal health efforts. Digital stories add richness to ongoing maternal health prevention work and may serve as a powerful tool to elicit understanding among providers, practitioners, and constituents.

The association of COVID-19 infection in pregnancy with preterm birth: A retrospective cohort study in California.

INTRODUCTION: Our understanding of the association between coronavirus disease 19 (COVID-19) and preterm or early term birth among racially and ethnically diverse populations and people with chronic medical conditions is limited. METHODS: We determined the association between COVID-19 and preterm (PTB) birth among live births documented by California Vital Statistics birth certificates between July 2020 and January 2021 (n=240,147). We used best obstetric estimate of gestational age to classify births as very preterm (VPTB, <32 weeks), PTB (< 37 weeks), early term (37 and 38 weeks), and term (39-44 weeks), as each confer independent risks to infant health and development. Separately, we calculated the joint effects of COVID-19 diagnosis, hypertension, diabetes, and obesity on PTB and VPTB. FINDINGS: COVID-19 diagnoses on birth certificates increased for all racial/ethnic groups between July 2020 and January 2021 and were highest for American Indian/Alaska Native (12.9%), Native Hawaiian/Pacific Islander (11.4%), and Latinx (10.3%) birthing people. COVID-19 diagnosis was associated with an increased risk of VPTB (aRR 1.6, 95% CI [1.4, 1.9]), PTB (aRR 1.4, 95% CI [1.3, 1.4]), and early term birth (aRR 1.1, 95% CI [1.1, 1.2]). There was no effect modification of the overall association by race/ethnicity or insurance status. COVID-19 diagnosis was associated with elevated risk of PTB in people with hypertension, diabetes, and/or obesity. INTERPRETATION: In a large population-based study, COVID-19 diagnosis increased the risk of VPTB, PTB, and early term birth, particularly among people with medical comorbidities. Considering increased circulation of COVID-19 variants, preventative measures, including vaccination, should be prioritized for birthing persons. FUNDING: UCSF-Kaiser Department of Research Building Interdisciplinary Research Careers in Women's Health Program (BIRCWH) National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women's Health (ORWH) [K12 HD052163] and the California Preterm Birth Initiative, funded by Marc and Lynn Benioff.

Police brutality and unmet need for mental health care.

OBJECTIVE: National movements have raised awareness of the adverse mental health effects of police brutality. This study examines the relationship between perceived police brutality and unmet need for mental health care. DATA SOURCES: We used the 2018 Survey of the Health of Urban Residents (N = 4338), a quota sample survey of adults in urban areas in the contiguous United States. STUDY DESIGN: Multivariate regressions were used to understand the association between police brutality and unmet need for mental health care. Unmet need was regressed on police brutality (the independent variable), controlling for sociodemographic and health status characteristics of respondents and access to care. We then stratified the sample by experiences of police brutality (no negative encounters with the police, encounters that were perceived as necessary, and encounters that were considered unnecessary) and described how medical mistrust and perceived respect within health care settings were associated with odds of unmet need for each subsample. DATA COLLECTION: Data were collected online. PRINCIPAL FINDINGS: Negative police encounters perceived as necessary were associated with greater odds of unmet need compared to no negative police encounters (odds ratio [OR] = 1.98, confidence interval [CI] = 1.30-2.65). Odds of unmet need were also higher among persons with negative and unnecessary police encounters (OR = 1.28, CI = 1.05-1.56). Greater respect was associated with lower odds of unmet need among persons who reported negative unnecessary encounters with the police (OR = 0.88, CI = 0.72-0.97). Medical mistrust was associated with greater odds of unmet need among those with negative unnecessary police encounters (OR = 1.52, CI = 1.12-1.93). CONCLUSIONS: Persons who are exposed to police brutality are also likely to be those who experience unmet need for mental health care. Ensuring that they feel respected within medical settings and establishing conditions that build trust in medical institutions are important for eliminating unmet need for mental health care.

'Asram is really killing us here': attribution for pregnancy losses and newborn mortality in the Ashanti Region of Ghana.

While overall neonatal mortality rates are improving in Ghana, the Ashanti Region has the highest mortality rate in the country. The clinical causes of newborn deaths are well known, yet local beliefs about illness aetiology, cause of death and care-seeking are less well understood. This exploratory qualitative study sought to understand how community members perceive and respond to neonatal illness. Researchers worked with public health nurses, community health nurses and opinion leaders in the Ashanti Region of Ghana to identify women who had lost a baby, either during pregnancy or after delivery. In-depth interviews and focus group discussions were conducted about knowledge, attitudes and beliefs regarding neonatal mortality. The transcripts were coded and analysed using NVivo 10.0. A total of 100 participants were interviewed: 24% reported a previous stillbirth; 37% reported a previous miscarriage; and 45% reported losing a baby who was born alive. Nine per cent experienced more than one type of loss. The local illness of asram - an illness with supernatural causes - was cited as a leading cause of death of newborns. Every participant reported hearing of, knowing someone, or having a child who had become ill with asram. While women gave varying information on symptoms, method of contraction and treatment, all participants agreed that asram was common and often fatal. Four overarching themes emerged: 1) asram is not a hospital sickness; 2) there is both a fear of traditional healers as a source of asram, as well as a reliance upon them to cure asram; 3) there are rural/urban differences in perceptions of asram; and 4) asram may serve as a mechanism of social control for pregnant women and new mothers. Local beliefs and practices must be better understood and incorporated into health education campaigns if neonatal mortality is to be reduced in Ghana.

'This sickness is not hospital sickness': a qualitative study of the evil eye as a source of neonatal illness in Ghana.

Previous research has described the evil eye as a source of illness for pregnant women and their newborns. This study sought to explore the perceptions of the evil eye among mothers whose newborns had experienced a life-threatening complication across three regions of Ghana. As part of a larger, quantitative study, trained research assistants identified pregnant and newly delivered women (and their newborns) who had survived a life-threatening complication at three tertiary care hospitals in southern Ghana to participate in open-ended, qualitative interviews about their experiences in March-August 2015. All interviews were audio-recorded and transcribed verbatim into English and analysis using the constant comparative method of theme generation. A total of 37 mothers were interviewed, 20 about neonatal illnesses and 17 about maternal illnesses. Six of the 20 mothers interviewed about their newborn's illnesses spoke at length about the evil eye being a potential cause of newborn illness. The evil eye was described in a variety of terms, but commonalities included a person looking at a pregnant woman, her newborn baby, the baby's clothes and even the mother's food, causing harm, even unintentionally. Prevention required mothers covering themselves while pregnant and keeping the baby away from others until it was old enough to ward off the evil eye. Treatment required traditional medicine, yet some indicated that allopathic medicine could help. The evil eye appears to serve a social control mechanism, encouraging pregnant women to dress modestly, stay indoors as much as possible and behave appropriately. The evil eye is a pervasive, universally understood phenomenon across three regions of Ghana, even amongst a hospitalized population receiving allopathic health care for life-threatening complications of childbirth. Understanding the role of the evil eye in newborn illness attribution is important for clinicians, researchers and programmatic staff to effectively address barriers to care seeking.

Neonatal near-misses in Ghana: a prospective, observational, multi-center study.

BACKGROUND: For every newborn who dies within the first month, as many as eight more suffer life-threatening complications but survive (termed 'neonatal near-misses' (NNM)). However, there is no universally agreed-upon definition or assessment tool for NNM. This study sought to describe the development of the Neonatal Near-Miss Assessment Tool (NNMAT) for low-resource settings, as well as findings when implemented in Ghana. METHODS: This prospective, observational study was conducted at two tertiary care hospitals in southern Ghana from April - July 2015. Newborns with evidence of complications and those admitted to the NICUs were screened for inclusion using the NNMAT. Incidence of suspected NNM at enrollment and confirmed near-miss (surviving to 28 days) was determined and compared against institutional neonatal mortality rates. Suspected NNM cases were compared with newborns not classified as a suspected near-miss, and all were followed to 28 days to determine odds of survival. Confirmed near-misses were those identified as suspected near-misses at enrollment who survived to 28 days. The main outcome measures were incidence of NNM, NNM:mortality ratio, and factors associated with NNM classification. RESULTS: Out of 394 newborns with complications, 341 (86.5%) were initially classified as suspected near-misses at enrollment using the NNMAT, with 53 (13.4%) being classified as a non-near-miss. At 28-day follow-up, 68 (17%) had died, 52 (13%) were classified as a non-near-miss, and 274 were considered confirmed near-misses. Those newborns with complications who were classified as suspected near-misses using the NNMAT at enrollment had 12 times the odds of dying before 28 days than those classified as non-near-misses. While most confirmed near-misses qualified as NNM via intervention-based criteria, nearly two-thirds qualified based on two or more of the four NNMAT categories. When disaggregated, the most predictive elements of the NNMAT were gestational age < 33 weeks, neurologic dysfunction, respiratory dysfunction, and hemoglobin < 10 gd/dl. The ratio of near-misses to deaths was 0.55: 1, yet this varied across the study sites. CONCLUSIONS: This research suggests that the NNMAT is an effective tool for assessing neonatal near-misses in low-resource settings. We believe this approach has significant systems-level, continuous quality improvement, clinical and policy-level implications.

Is abortion justified to save the life or health of a woman? Evidence of public opinion from Accra, Ghana.

OBJECTIVE: In this study, we sought to determine to what extent the abortion law in Ghana is reflective of public opinion. METHODS: In a cross-sectional, community-based survey, individuals in two fishing communities in Accra were interviewed about their beliefs on abortion between May and July 2016, and sociodemographic, attitudinal, and experience data were collected. Factors associated with the outcome variable (abortion is justified to save the life/health of the woman: Yes/No) were entered into a multivariate logistic regression. RESULTS: A total of 508 participants completed the survey. Thirty-nine percent (n=198) of the sample agreed that abortion was justified to save the life/health of the woman, with no significant differences in this finding when controlling for understanding of the law, gender, marital status, or personal experience of abortion in multivariate analysis. Higher education (odds ratio [OR] 1.64 [P<0.001]) and older age (OR 1.28 [P<0.001]) are positively associated with abortion being justified to save life/health, while those who have had an experience of unwanted sex are less likely to believe that (OR 0.60 [P=0.029]). CONCLUSION: The participants held conservative views about the justification of abortion to save a woman's life and/or health. Improving access to safe abortion services will require acknowledgment of the broader social and cultural context that may make accessing such services difficult.

"We call them miracle babies": How health care providers understand neonatal near-misses at three teaching hospitals in Ghana.

Neonatal mortality is a significant problem in many low-resource countries, yet for every death there are many more newborns who suffer a life-threatening complication but survive. These "near-misses" are not well defined, nor are they well understood. This study sought to explore how health care providers at three tertiary care centers in Ghana (each with neonatal intensive care units (NICUs)) understand the term "near-miss." Eighteen providers from the NICUs at three teaching hospitals in Ghana (Korle Bu Teaching Hospital in Accra, Komfo Anokye Teaching Hospital in Kumasi, and Cape Coast Teaching Hospital in Cape Coast) were interviewed in depth regarding their perceptions of neonatal morbidity, mortality, and survival. Near the end of the interview, they were specifically asked what they understood the term "near-miss" to mean. Participants included nurses and physicians at various levels and with varying years of practice (mean years of practice = 9.33, mean years in NICU = 3.66). Results indicate that the concept of "near-misses" is not universally understood, and providers differ on whether a baby is a near-miss or not. Providers disagreed on the utility of a near-miss classification for clinical practice, with some suggesting it would be helpful to draw their attention to those at highest risk of dying, with others suggesting that the acuity of illness in a NICU means any baby could become a 'near-miss' at any moment. Further efforts are needed to standardize the definitions of neonatal near-misses, including developing criteria that are able to be assessed in a low-resource setting. In addition, further research is warranted to determine the practical implications of using a near miss tool in the process of providing care in a resource-limited setting and whether it might be best reserved as a retrospective indicator of overall quality of care provided.

Short-Term Rationing of Combination Antiretroviral Therapy: Impact on Morbidity, Mortality, and Loss to Follow-Up in a Large HIV Treatment Program in Western Kenya.

Background. There was a 6-month shortage of antiretrovirals (cART) in Kenya. Methods. We assessed morbidity, mortality, and loss to follow-up (LTFU) in this retrospective analysis of adults who were enrolled during the six-month period with restricted cART (cap) or the six months prior (pre-cap) and eligible for cART at enrollment by the pre-cap standard. Cox models were used to adjust for potential confounders. Results. 9009 adults were eligible for analysis: 4,714 pre-cap and 4,295 during the cap. Median number of days from enrollment to cART initiation was 42 pre-cap and 56 for the cap (P < 0.001). After adjustment, individuals in the cap were at higher risk of mortality (HR = 1.21; 95% CI : 1.06-1.39) and LTFU (HR = 1.12; 95% CI : 1.04-1.22). There was no difference between the groups in their risk of developing a new AIDS-defining illness (HR = 0.92 95% CI 0.82-1.03). Conclusions. Rationing of cART, even for a relatively short period of six months, led to clinically adverse outcomes.

Determinants of condom use among female sex workers in Kenya: a case-crossover analysis.

BACKGROUND: We evaluated predictors of consistent condom use among female sex workers (FSWs), a core group for controlling the spread of HIV. METHODS: In an analysis of data collected in 2004-2005 from 140 Kenyan FSWs who completed questionnaires administered during a baseline study visit and three bimonthly follow-up visits, we used a case-crossover design to identify predictors of consistent condom use during all coital acts in the preceding 2 weeks, overall and by partner type. RESULTS: Participants (n=140) completed the baseline visit and 390 bimonthly follow-up visits. Alcohol use during sex was negatively associated with consistent condom use with helping partners (defined as regular sex partners to whom the woman could go for help or support if needed) (adjusted odds ratio [AOR], 2.6, 95% confidence interval [CI] 1.0-6.5) but not associated with condom use with other partners. Coital frequency was associated with condom use with other partners only. Women who reported 1-5 (AOR 11.0, 95% CI 4.3-28.3) or 6-9 recent coital acts (AOR 3.8, 95% CI 1.7-8.8) with other partners were more likely to report consistent condom use with those partners than were women who reported ≥10 acts. Having a recent partner delay payment was inversely associated with consistent condom use with helping, other, or all partners. CONCLUSIONS: Correlates of consistent condom use differed by partner type. By using a case-crossover design, we were able to identify potentially modifiable factors associated with consistent condom use by FSWs who used condoms consistently with a given partner type during some periods but not others.

Assessment of changes in condom use among female sex workers in a prospective cohort study introducing diaphragm use for disease prevention.

Changes in the rates of condom use and number of sexual partners were evaluated among 140 female sex workers in Kibera, Kenya, participating in a 6-month study of diaphragm safety and acceptability for prevention of sexually transmitted infections conducted in 2004-2005. Analyses were stratified by partner type. Multivariable Tobit regression modeling was used to assess the association between study visit and proportion of acts protected. Participants completed 140 baseline visits and 390 bimonthly follow-up visits. The mean percentage of coital acts reported as protected by a condom increased from 56% at baseline to 68% at the 6-month visit (P < 0.01). Similar increases were observed for condom use by all partner types. Additionally, the mean number of sexual partners decreased over the study. Furthermore, consistent (i.e., 100%) diaphragm use during follow-up was associated with a higher proportion of coital acts protected by a condom in analyses adjusted for study visit and coital frequency. These findings suggest that, despite concerns that introduction of the diaphragm would result in more risky sexual behaviors, reported condom use increased and number of partners decreased.

Diaphragm for STI and HIV prevention: is it a safe method for women at high risk?

Female sex workers (n = 140) were enrolled in a 6-month acceptability trial of the diaphragm. We randomized a subset (n = 40) to receive colposcopies after 1 month of diaphragm use or after 1 month of observation before commencing diaphragm use. Adverse events were mild in nature. Frequency of colposcopic findings did not differ between women randomized to immediate versus delayed diaphragm use (P = 0.25).

Intravaginal practices among female sex workers in Kibera, Kenya.

OBJECTIVES: To assess vaginal cleansing and lubricant use among female sex workers (FSW) in Kenya participating in a 6-month, prospective study of the acceptability of the use of the diaphragm. METHODS: The study is based on 140 FSW in Nairobi, who completed 140 baseline visits and 390 bi-monthly follow-up visits. Participants were instructed to wear the diaphragm for all coital acts during follow-up and to refrain from vaginal cleansing while wearing the diaphragm. Logistic regression was used to identify predictors of recent vaginal cleansing to 'tighten' the vagina reported at baseline; recent vaginal cleansing to prevent infection reported at baseline; recent vaginal cleansing with the diaphragm in place reported during follow-up; and recent use of oil-based lubricant during coitus reported at baseline. RESULTS: At baseline, 99% of women reported vaginal cleansing in the previous 2 weeks for purposes of hygiene or to remove evidence of past coitus. Approximately 41% of women also reported cleansing in the past 2 weeks to 'tighten' the vagina. Women reported vaginal cleansing with the diaphragm in place in the past 2 weeks at 14% of follow-up visits in which the diaphragm was used. Predictors of such cleansing included young age, 6-month study visit, being divorced or widowed and higher educational level. CONCLUSIONS: While vaginal cleansing is a modifiable behaviour, given that cleansing for hygiene was almost universal among this study population at baseline and that more women reported cleansing while wearing the diaphragm as the study progressed, the complete eradication of the practice would probably be difficult.

Promoting continuous use as a strategy for achieving adherence in a trial of the diaphragm with candidate microbicide.

Women need more choices for protection from HIV and other sexually transmitted infections (STIs). We conducted a randomized 4-week study in Madagascar in preparation for a Phase III randomized controlled trial (RCT) of the diaphragm with a candidate microbicide for STI prevention. All participants completed quantitative surveys; half participated in a qualitative interview. We advised women to wear the diaphragm at all times except for daily cleaning (rather than inserting it before intercourse). The objective of this analysis was to determine whether women who followed this "continuous use" approach more often used the diaphragm for 100% of sex acts as compared with other women. If so, this would support advising continuous diaphragm use in the upcoming RCT. To meet our objective, we analyzed qualitative data thematically, developed a measure of continuous diaphragm use based on qualitative data, and used multiple regression to evaluate the measure's association with adherence to diaphragm use during 100% of sex acts. Women who wore the diaphragm continuously had 4 times higher odds of reporting diaphragm use during 100% of sex acts (OR: 4.6, 95% CI: 1.2, 24.0). If the diaphragm proves effective against STI, continuous use may help women achieve high levels of protection.

Predictors of adherent use of diaphragms and microbicide gel in a four-arm, randomized pilot study among female sex workers in Madagascar.

BACKGROUND: Participants' protocol adherence may influence assessments of the effectiveness of new female-controlled methods for sexually transmitted infection prevention. METHODS: In 2005 we conducted a randomized pilot study among female sex workers (FSWs) in Madagascar in preparation for sexually transmitted infection prevention trial of diaphragms and a vaginal microbicide. Participants (n = 192) were randomized into 4 arms: diaphragm plus microbicide (Acidform), diaphragm plus placebo gel hydroxyethyl cellulose (HEC), Acidform alone, or HEC alone. FSWs were seen weekly for 4 weeks. Using multivariable regression with generalized estimating equations, we assessed predictors of adherent product use during all sex acts in the last week. We collapsed the gel-diaphragm arms together and the gel-only arms together for this analysis. RESULTS: Between 43% and 67% of gel-diaphragm users (varying by visit) reported using study products during all sex acts in the last week, compared with 20% to 45% of gel-only users. Adherence increased with follow-up [visit 4 vs. visit 1 risk ratio (RR) for gel-diaphragm users: 1.55, P <0.01; for gel-only users, RR: 1.58, P = 0.01]. Gel-diaphragm users whose casual partners were never aware of products (RR: 2.02, P = 0.03) and who had experienced partner violence after requesting condom use (RR: 1.45, P <0.01) were more adherent. Gel-only users reporting lower sexual frequency (1-9 weekly acts vs. >or=19 acts, RR: 1.98, P <0.01) and no sex with primary partners in the past week (RR: 1.54, P = 0.02) were more adherent. CONCLUSIONS: Gel-diaphragm users had better adherence than gel-only users, and predictors of adherence differed between groups. Addressing modifiable factors during counseling sessions may improve adherence.

Adherence to diaphragm use for infection prevention: a prospective study of female sex workers in Kenya.

OBJECTIVE: To assess adherence to and acceptability of the diaphragm among 140 female sex workers in Kenya in a 6-month prospective study. METHODS: At baseline and bimonthly visits, participants were interviewed on diaphragm knowledge, attitude, and practices. We used principal component analysis and logistic regression to identify predictors of consistent use. RESULTS: At 50% of 386 bimonthly visits, women reported consistently using a diaphragm with all partners during the preceding 2 weeks. Consistent use was significantly higher at the 6-month than the 2-month visit. Women reported less covert use with "helping" (regular sex partners to whom she could go for help or support) than with "other" partners. Perceptions that diaphragms are easier to use than condoms and that their lack of coital interruption is important were associated with consistent diaphragm use with both partner types. Partner support of diaphragm use is correlated with consistent use with "helping" partners only while higher parity, consistent condom use, and perceived lack of need of condoms as a benefit of diaphragms were associated with consistent use with "other" partners. CONCLUSIONS: Diaphragm acceptance among female sex workers in Nairobi was high. Future studies should distinguish between partner types when evaluating diaphragm adherence.

Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar.

BACKGROUND: In preparation for a randomized controlled trial (RCT), we conducted a pilot RCT of the acceptability and feasibility of diaphragms and candidate vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar. METHODS: Participants were randomized to four arms: (1) diaphragm (worn continuously) with Acidform applied in the dome; (2) diaphragm (worn continuously) with placebo gel hydroxyethylcellulose (HEC) in the dome; (3) HEC applied intravaginally before sex; (4) Acidform applied intravaginally before sex. All women were given condoms. Participants were followed weekly for 4 weeks. We fit unadjusted negative binomial regression models with robust variance estimators to generate the proportion of sex acts with casual partners where condoms and experimental study products were used. RESULTS: Retention was 98% among 192 participants. Experimental product use with casual partners was high, reported in 85%, 91%, 74%, and 81% of sex acts for women in the Acidform-diaphragm, HEC-diaphragm, HEC-alone, and Acidform-alone arms, respectively. However, the proportion reporting product use during 100% of acts with casual partners over the full follow-up period was much lower: 28% to 29% in the gel-diaphragm arms and 6% to 10% in gel-alone arms. Women used condoms in 62% to 67% of sex acts with casual partners, depending on the randomization arm. Participants found diaphragms easy to insert (97%) and remove (96%). Acidform users (with or without the diaphragm) reported more genitourinary symptoms than HEC users (14% vs. 5% of visits). CONCLUSIONS: A sexually transmitted infection prevention RCT of candidate microbicide with and without the diaphragm appears acceptable and feasible in this population.

Barriers to the use of modern contraceptives and implications for woman-controlled prevention of sexually transmitted infections in Madagascar.

Globally, unplanned pregnancies and sexually transmitted infections (STIs) persist as significant threats to women's reproductive health. Barriers to the use of modern contraceptives by women might inhibit uptake of novel woman-controlled methods for preventing STIs/HIV. Use of modern contraceptives and perceptions and attitudes towards contraceptive use were investigated among women in Antananarivo, Madagascar, using qualitative research. The hypothetical acceptability of the diaphragm--a woman-controlled barrier contraceptive device that also holds promise of protecting against STIs/HIV--was assessed. Women consecutively seeking care for vaginal discharge at a public health clinic were recruited for participation in a semi-structured interview (SSI) or focus group discussion (FGD). Audiotaped SSIs and FGDs were transcribed, translated and coded for predetermined and emerging themes. Of 46 participating women, 70% reported occasional use of male condoms, mostly for preventing pregnancy during their fertile days. Although women could name effective contraceptive methods, only 14% reported using hormonal contraception. Three barriers to use of modern contraceptives emerged: gaps in knowledge about the range of available contraceptive methods; misinformation and negative perceptions about some methods; and concern about social opposition to contraceptive use, mainly from male partners. These results demonstrate the need for programmes in both family planning and STI prevention to improve women's knowledge of modern contraceptives and methods to prevent STI and to dispel misinformation and negative perceptions of methods. In addition, involvement of men will probably be a critical component of increased uptake of woman-controlled pregnancy and STI/HIV prevention methods and improved health.

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm.

OBJECTIVES: To assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk, sexually abstinent women. STUDY DESIGN: Eighty-one women enrolled in a randomized, masked, phase I safety study using a diaphragm with Acidform, BufferGel, or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination, colposcopy, and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability. RESULTS: Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated. CONCLUSIONS: Acidform and BufferGel compared to KY Jelly, when used with diaphragm daily for 14 days, appeared to be safe and acceptable in a small study of low-risk abstinent women.