Comparison of breath sampling methods: a post hoc analysis from observational cohort studies.

In this report, we present a post hoc analysis from two observational cohorts, comparing the global breath volatile profile captured when using polymer sampling bags (mixed breath) versus Bio-VOC™ (alveolar breath). The cohorts were originally designed to characterize the breath volatile profiles of Malawian children with and without uncomplicated falciparum malaria. Children aged 3-15 years were recruited from ambulatory pediatric centers in Lilongwe, Malawi. Breath sampling was carried out two months apart (one study using a Bio-VOC™ and the second using sampling bags), and all samples were analyzed by gas chromatography/mass spectrometry. The efficacy of breath collection was assessed by quantifying levels of two high prevalence breath compounds, acetone and isoprene, as well as determining the overall number of breath compounds collected and their abundance. We found that the mean number of volatiles detected using sampling bags was substantially higher than when using the Bio-VOC™ (137 vs. 47). Breath collection by Bio-VOC™ also yielded reduced levels of endogenous breath volatiles, isoprene and acetone, even after breath volume correction. This suggests that the Bio-VOC™ dilutes the volatiles and introduces dead air or ambient air. Our results suggest that sampling bags are better suited for biomarker discovery and untargeted search of volatiles in pediatric populations, as evidenced by superior breath volatile detection.

Influences on birth spacing intentions and desired interventions among women who have experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study.

BACKGROUND: Stillbirth and neonatal mortality are very high in many low-income countries, including Malawi. Use of family planning to encourage birth spacing may optimize outcomes for subsequent pregnancies. However, reproductive desires and influences on birth spacing preferences of women who have experienced a stillbirth or neonatal death in low-resource settings are not well understood. METHODS: We conducted a qualitative study using 20 in-depth interviews and four focus group discussions with women who had experienced a stillborn baby or early neonatal death to explore attitudes surrounding birth spacing and potential interventions to promote family planning in this population. Qualitative data were analyzed for recurrent patterns and themes and central ideas were extracted to identify their core meanings. RESULTS: Forty-six women participated in the study. After experiencing a stillbirth or neonatal death, most women wanted to wait to become pregnant again but women with living children wished to wait for longer periods of time than those with no living children. Most women preferred birth spacing interventions led by clinical providers and inclusion of their spouses. CONCLUSIONS: Many influences on family size and birth spacing were noted in this population, with the most significant influencing factor being the spouse. Interventions to promote birth spacing and improve maternal and neonatal health in this population need to involve male partners and knowledgeable health care providers to be effective. TRIAL REGISTRATION: Clinicaltrials.gov NCT02674542 Registered February 1, 2016 (retrospectively registered).

Pelvic Ultrasound Findings in Women with Obstetric Fistula: A Cross-Sectional Study of Cases and Controls.

OBJECTIVE: Obstetric fistula (OF) is a morbid condition caused by prolonged obstructed labor. Women with OF experience profound injury and have high rates of infertility and poor obstetric outcomes. We examined endovaginal ultrasound parameters in women with and without OF. DESIGN/SETTING/SAMPLE/METHODS: This cross-sectional study enrolled women evaluated at the Fistula Care Centre in Lilongwe, Malawi. Eligibility criteria included age 18-45, prior pregnancy, and a uterus on ultrasound. Participants underwent endovaginal ultrasound with measurement of cervical dimensions. Comparisons were done using t-tests and Fisher's exact test. Among women with OF, linear regression was used to assess whether fistula stage was associated with cervical length. RESULTS: We enrolled 98 cases and 12 controls. Women with OF had shorter cervical lengths (18.8 mm versus 27.3 mm, p < 0.01), as well as shorter anterior (7.0 mm versus 9.3 mm, p < 0.01) and posterior (9.5 mm versus 11.0 mm, p < 0.04) cervical stroma, compared to controls. CONCLUSION: Women with OF have shorter cervical lengths and anterior and posterior cervical stroma, when compared to women without OF. This may offer a partial explanation for subfertility and poor obstetric outcomes in OF patients. Additional studies to clarify the role of ultrasound in OF patients and prediction of future fertility are warranted.

Breathprinting Reveals Malaria-Associated Biomarkers and Mosquito Attractants.

Current evidence suggests that malarial infection could alter metabolites in the breath of patients, a phenomenon that could be exploited to create a breath-based diagnostic test. However, no study has explored this in a clinical setting. To investigate whether natural human malarial infection leads to a characteristic breath profile, we performed a field study in Malawi. Breath volatiles from children with and those without uncomplicated falciparum malaria were analyzed by thermal desorption-gas chromatography/mass spectrometry. Using an unbiased, correlation-based analysis, we found that children with malaria have a distinct shift in overall breath composition. Highly accurate classification of infection status was achieved with a suite of 6 compounds. In addition, we found that infection correlates with significantly higher breath levels of 2 mosquito-attractant terpenes, α-pinene and 3-carene. These findings attest to the viability of breath analysis for malaria diagnosis, identify candidate biomarkers, and identify plausible chemical mediators for increased mosquito attraction to patients infected with malaria parasites.

Schistosomiasis among obstetric fistula patients in Lilongwe, Malawi.

BACKGROUND: Schistosoma haematobium infection has been documented as an uncommon cause of vesicovaginal fistula (VVF) and can result in impaired wound healing of urogenital tissues. For these reasons, it could potentially be linked to an increased rate of obstetric fistula among women who experience obstructed labor and/or in a higher failure rate of fistula repair. Therefore, the primary objective of our study was to determine the prevalence of S. haematobium infection among women undergoing obstetric VVF repair in Lilongwe, Malawi. Our secondary objectives were to assess if S. haematobium infection could be a risk factor for obstetric fistula development or unsuccessful VVF repair in our patient population. METHODS: From July to October 2013, we conducted S. haematobium testing via urine microscopy on 96 patients undergoing obstetric VVF repair surgery at the Fistula Care Centre in Lilongwe, Malawi. RESULTS: The prevalence of S. haematobium infection among women undergoing obstetric VVF repair was 2% (n=2). Both women with S. haematobium had successful VVF repairs. CONCLUSIONS: Although S. haematobium has the potential to be a risk factor for obstetric VVF formation or unsuccessful VVF repair, it was uncommon among the women in our clinic with obstetric VVF.

Dual Method Use among Postpartum HIV-Infected and HIV-Uninfected Malawian Women: A Prospective Cohort Study.

Dual method use, use of condoms plus another effective contraceptive method, is important in settings with high rates of unintended pregnancy and HIV infection. We evaluated the association of HIV status with dual method use in a cohort of postpartum women. Women completed baseline surveys in the postpartum ward and telephone surveys about contraceptive use 3, 6, and 12 months later. Nonpregnant women who completed at least one follow-up survey were eligible for this secondary analysis. Prevalence ratios were calculated using generalized estimating equations. Of the 511 sexually active women who completed a follow-up survey, condom use increased from 17.6% to 27.7% and nonbarrier contraceptive use increased from 73.8% to 87.6% from 3 to 12 months after delivery. Dual method use increased from 1.0% to 18.9% at 3 to 12 months after delivery. Dual method use was negligible and comparable between HIV-infected and HIV-uninfected women at 3 months but significantly higher among HIV-infected women at 6 months (APR = 3.9, 95% CI 2.2, 7.1) and 12 months (APR = 2.7, 95% CI 1.7, 4.3). Dual method use was low but largely driven by condom use among HIV-infected women at 6 and 12 months after delivery.

Soya, maize, and sorghum-based ready-to-use therapeutic food with amino acid is as efficacious as the standard milk and peanut paste-based formulation for the treatment of severe acute malnutrition in children: a noninferiority individually randomized controlled efficacy clinical trial in Malawi.

Background: Development of more cost-effective ready-to-use therapeutic food (RUTF) is a global public health priority. To date, previous lower-cost recipes have been less effective than the standard peanut and milk (PM)-based RUTF, particularly in children aged <24 mo.Objective: We aimed to compare the efficacy of the PM-RUTF to a milk-free soya, maize, and sorghum (FSMS)-RUTF enriched with crystalline amino acids without cow milk powder and a milk, soya, maize, and sorghum (MSMS)-RUTF containing 9.3% skim cow milk powder.Design: This nonblinded, 3-arm, parallel-group, simple randomized controlled trial enrolled Malawian children with severe acute malnutrition.Results: In intention-to-treat analyses, FSMS-RUTF showed noninferiority for recovery rates in children aged 24-59 mo (Δ: -1.9%; 95% CI: -9.5%, 5.6%) and 6-23 mo (Δ: -0.2%; 95% CI: -7.5%, 7.1%) compared with PM-RUTF. MSMS-RUTF also showed noninferiority for recovery rates in children aged 24-59 mo (Δ: 0.0%; 95% CI: -7.3%, 7.4%) and 6-23 mo (Δ: 0.6%; 95% CI: -4.3%, 5.5%). Noninferiority in recovery rates was also observed in per-protocol analyses. For length of stay in the program (time to cure), both FSMS-RUTF in children aged 24-59 mo (Δ: 2.8 d; 95% CI: -0.8, 6.5 d) and 6-23 mo (Δ: 3.4 d; 95% CI: -1.2, 8.0 d) and MSMS-RUTF in children aged 24-59 mo (Δ: 0.2 d; 95% CI: -3.1, 3.6 d) and 6-23 mo (Δ: 1.2 d; 95% CI: -3.4, 5.8 d) were not inferior to PM-RUTF. FSMS-RUTF was also significantly better than PM-RUTF at increasing hemoglobin and body iron stores in anemic children, with mean hemoglobin increases of 2.1 (95% CI: 1.6, 2.6) and 1.3 (95% CI: 0.9, 1.8) and mean body iron store increases of 2.0 (95% CI: 0.8, 3.3) and 0.1 (95% CI: -1.1, 1.3) for FSMS-RUTF and PM-RUTF, respectively.Conclusions: FSMS-RUTF without milk is efficacious in the treatment of severe acute malnutrition in children aged 6-23 and 24-59 mo. It is also better at correcting iron deficiency anemia than PM-RUTF. This trial was registered at www.pactr.org as PACTR201505001101224.

Contraceptive uptake after training community health workers in couples counseling: A cluster randomized trial.

BACKGROUND: Young women in Malawi face many challenges in accessing family planning (FP), including distance to the health facility and partner disapproval. Our primary objective was to assess if training HSAs in couples counseling would increase modern FP uptake among young women. METHODS: In this cluster randomized controlled trial, 30 HSAs from Lilongwe, Malawi received training in FP. The HSAs were then randomized 1:1 to receive or not receive additional training in couples counseling. All HSAs were asked to provide FP counseling to women in their communities and record their contraceptive uptake over 6 months. Sexually-active women <30 years of age who had never used a modern FP method were included in this analysis. Generalized estimating equations with an exchangeable correlation matrix to account for clustering by HSA were used to estimate risk differences (RDs) and 95% confidence intervals (CIs). RESULTS: 430 (53%) young women were counseled by the 15 HSAs who received couples counseling training, and 378 (47%) were counseled by the 15 HSAs who did not. 115 (26%) from the couples counseling group had male partners present during their first visit, compared to only 6 (2%) from the other group (RD: 0.21, 95% CI: 0.09 to 0.33, p<0.01). Nearly all (99.5%) initiated a modern FP method, with no difference between groups (p = 0.09). Women in the couples counseling group were 8% more likely to receive male condoms (RD: 0.08, 95% CI: -7% to 23%, p = 0.28) and 8% more likely to receive dual methods (RD: 0.08, 95% CI: -0.065, 0.232, p = 0.274). CONCLUSION: Training HSAs in FP led to high modern FP uptake among young women who had never used FP. Couples counseling training increased male involvement with a trend towards higher male condom uptake.

Patterns of Contraceptive Adoption, Continuation, and Switching after Delivery among Malawian Women.

Women who report use of postpartum family planning may not continue their initial method or use it consistently. Understanding the patterns of method uptake, discontinuation, and switching among women after delivery is important to promote uptake and continuation of effective methods of contraception. This is a secondary analysis of 634 Malawian women enrolled into a prospective cohort study after delivery. They completed baseline surveys upon enrollment and follow-up telephone surveys 3, 6, and 12 months post-delivery. Women were included in this analysis if they had completed at least the 3- and 6-month post-delivery surveys. Descriptive statistics were used to assess contraceptive method mix and patterns of switching, whereas Pearson's χ2 tests were used for bivariable analyses to compare characteristics of women who continued and discontinued their initial post-delivery contraceptive method. Among the 479 women included in this analysis, the use of abstinence/traditional methods decreased and the use of long-acting and permanent methods (LAPM) increased over time. Almost half (47%) discontinued the contraceptive method reported at 3-months post-delivery; women using injectables or LAPM at 3-months post-delivery were significantly more likely to continue their method than those using non-modern methods (p<0.001). Of the 216 women who switched methods, 82% switched to a more or equally effective method. The change in contraceptive method mix and high rate of contraceptive switching in the first 12 months postpartum highlights a need to assist women in accessing effective contraceptives soon after delivery.

Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi.

INTRODUCTION: Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi. METHODS: A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering. RESULTS: Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4-14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1-10) were 2 (interquartile range, 2-4) during application and removal, and 0 (interquartile range, 0-2) at all other time points. CONCLUSIONS: Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.

Reproductive intentions and family planning practices of pregnant HIV-infected Malawian women on antiretroviral therapy.

The objective of this study was to describe the pregnancy intentions of pregnant HIV-infected Malawian women on antiretroviral therapy (ART) for at least 6 months prior to the current pregnancy, and to assess whether time on ART was associated with pregnancy intention. We conducted a cross-sectional analysis of HIV-infected Malawian women receiving antenatal care at a government hospital with a survey assessing ART history, reproductive history, and family planning use at conception. We used Pearson's chi-square tests and Fisher's exact tests to compare these parameters between women on ART greater than 24 months with those on ART less than 24 months. Modified Poisson regression was performed to assess the association between time on ART and pregnancy intention. Most women (75%) reported that their current pregnancy was unintended, defined as either Mistimed (21%) or Unwanted (79%). Women on ART for longer than 2 years were more likely to report an unintended pregnancy (79% versus 65%, p = .03), though there was no significant association between time on ART and pregnancy intention in multivariate analysis. Most women (79%) were using contraception at the time of conception, with condoms being most popular (91%), followed by injectables (9%) and the implant (9%). HIV-infected women on ART continue to experience high rates of unintended pregnancy in the Option B+ era. As Option B+ continues to be implemented in Malawi and increasing numbers of HIV-infected women initiate lifelong ART, ensuring that the most effective forms of contraception are accessible is necessary to decrease unintended pregnancy.

Long-term outcomes for women after obstetric fistula repair in Lilongwe, Malawi: a qualitative study.

BACKGROUND: Obstetric fistula affects a woman's life physically, psychosocially, and economically. Although surgery can repair the physical damage of fistula, the devastating consequences that affect a woman's quality of life may persist when she reintegrates into her community. This qualitative study assessed long-term outcomes among women who underwent obstetric fistula repair in Malawi. We explored three domains: overall quality of life before and after repair, fertility and pregnancy outcomes after repair, and understanding of fistula. METHODS: In-depth interviews were conducted in Chichewa with 20 women from seven districts across Central Malawi. All women were interviewed 1 to 2 years after surgical repair for obstetric fistula at the Fistula Care Centre in Lilongwe, Malawi. Interviews were independently coded and analyzed using content analysis. RESULTS: About half of women were married and nine of 20 women reported some degree of urinary incontinence. With the exception of relationship challenges, women's concerns before and after repair were different. Additionally, repair had resolved many of the concerns women had before repair. However, challenges, both directly and indirectly related to fistula, persisted. Improvements in quality of life at the individual level included feelings of freedom, confidence and personal growth, and improved income-earning ability. Interpersonal quality of life improvements included improved relationships with family and friends, reduced stigma, and increased participation with their communities. Nearly half of women desired future pregnancies, but many were uncertain about their ability to bear children and feared additional pregnancies could cause fistula recurrence. Most women were well informed about fistula development but myths about witchcraft and fear of delivery were present. Nearly all women would recommend fistula repair to other women, and many were advocates in their communities. CONCLUSIONS: Nearly all women believed their quality of life had improved at the individual and interpersonal levels since fistula repair, even among women who continued to have urinary incontinence. Contrary to other studies, women reported they were welcomed back by their communities and had limited challenges when reintegrating. Despite the overall improvements in quality of life, many continued to have relationship problems and were concerned about future fertility. These issues need to be further explored in other studies.

Association between contraceptive implant knowledge and intent with implant uptake among postpartum Malawian women: a prospective cohort study.

BACKGROUND: Long-acting reversible contraception (LARC) can assist women with birth spacing and reduce unintended pregnancies. Sub-Saharan Africa has low uptake of the two available methods of LARC, the subdermal implant and intrauterine contraception (IUC). Our primary objectives were to: 1) calculate the incidence of LARC use among postpartum Malawian women, and 2) assess if LARC knowledge and intent to use LARC were associated with LARC uptake. METHODS: This study was a prospective cohort study of 634 postpartum women who were recruited from the postpartum ward of Bwaila Hospital in Lilongwe, Malawi. Study participants completed a baseline survey in the postpartum ward. Follow-up telephone surveys about contraceptive use were conducted at 3, 6, and 12 months postpartum. Cox proportional hazards regression analysis was performed to evaluate if implant knowledge and intent to use implant were associated with implant uptake. RESULTS: One hundred thirty-seven implant and 10 IUC placements were reported over 12 months of follow-up; given the low rate of IUC uptake, further analysis was only done for implant uptake. The incidence rate for implant uptake was 35.6 per 100 person-years (95 % CI 30.0, 42.2). Correct implant knowledge (adjusted HR = 1.69; 95 % CI 1.06, 2.68) and intent to use implant (adjusted HR 1.95; 95 % CI 1.28, 2.98) were both associated with implant uptake. CONCLUSIONS: More women reported implant use than IUC use in our study. Correct implant knowledge and intent to use implant were both associated with implant uptake, with a stronger association for intent. Interventions to increase LARC uptake should focus on improving LARC knowledge and removing barriers to LARC. TRIAL REGISTRATION: Clinical Trial Registration #: NCT01893021.

Improvement and retention of emergency obstetrics and neonatal care knowledge and skills in a hospital mentorship program in Lilongwe, Malawi.

OBJECTIVE: To evaluate whether a hospital-based mentoring program could significantly increase short- and longer-term emergency obstetrics and neonatal care (EmONC) knowledge and skills among health providers. METHODS: In a prospective before-and-after study, 20 mentors were trained using a specially-created EmONC mentoring and training program at Bwaila Hospital in Lilongwe, Malawi. The mentors then trained an additional 114 providers as mentees in the curriculum. Mentors and mentees were asked to complete a test before initiation of the training (Pre-Test), immediately after training (Post-Test 1), and at least 6 months after training (Post-Test 2) to assess written and practical EmONC knowledge and skills. Mean scores were then compared. RESULTS: Scores increased significantly between the Pre-Test and Post-Test 1 for both written (n=134; difference 22.9%, P<0.001) and practical (n=125; difference 29.5%, P<0.001) tests. Scores were still significantly higher in Post-Test 2 than in the Pre-Test for written (n=111; difference 21.0%, P<0.001) and practical (n=103; difference 29.3%, P<0.001) tests. CONCLUSION: A hospital-based mentoring program can result in both short- and longer-term improvement in EmONC knowledge and skills. Further research is required to assess whether this leads to behavioral changes that improve maternal and neonatal outcomes.

Effect of HIV status on fertility desire and knowledge of long-acting reversible contraception of postpartum Malawian women.

The objectives of this study were to describe the most recent pregnancy intentions and family planning preferences of HIV-infected and HIV-uninfected postpartum Malawian women, and to assess whether HIV status is associated with fertility desire and knowledge of intrauterine contraception (IUC) and the subdermal contraceptive implant. We conducted a cross-sectional analysis of the baseline characteristics of Malawian women enrolled in a prospective cohort study assessing postpartum contraceptive uptake and continuation. Women at a government hospital completed a baseline survey assessing reproductive history, family planning preferences, and knowledge of IUC and the implant. We used Pearson's chi-square tests to compare these parameters between HIV-infected and HIV-uninfected women. Modified Poisson regression was performed to assess the association between HIV status and fertility desire and knowledge about IUC and the implant. Of 634 postpartum women surveyed, HIV-infected women were more likely to report their most recent pregnancy was unintended (49% vs. 37%, p = 0.004). Nearly all women (97%) did not want a child in the next 2 years, but HIV-infected women were more likely to desire no more children (adjusted prevalence ratio [PR]: 1.59; 95% confidence interval [CI]: 1.33, 1.89). HIV-infected women were also less likely to know that IUC (adjusted PR: 0.72; 95% CI: 0.61, 0.84) and the implant (adjusted PR: 0.83; 95% CI: 0.75, 0.92) are safe during breast-feeding. Postpartum women strongly desire family spacing and many HIV-infected postpartum women desire no more children, suggesting an important role for these long-acting methods. Education about the efficacy and safety of IUC and the implant particularly during breast-feeding may facilitate postpartum use.

Assessment of peer-based and structural strategies for increasing male participation in an antenatal setting in Lilongwe, Malawi.

In sub-Saharan Africa, although male involvement in antenatal care is associated with positive outcomes for HIV-infected women and their infants, men rarely accompany female partners. We implemented a project to increase the number of male partners attending an antenatal clinic at Bwaila Hospital in Lilongwe, Malawi. We evaluated changes in the proportion of women who came with a partner over three periods. During period 1 (January 2007 - June 2008) there was didactic peer education. During period 2 (July 2008 - September 2009) a peer-led male-involvement drama was introduced into patient waiting areas. During period 3 (October 2009 - December 2009) changes to clinical infrastructure were introduced to make the clinic more male-friendly. The proportion of women attending ANC with a male partner increased from 0.7% to 5.7%, to 10.7% over the three periods. Peer education through drama and male-friendly hospital infrastructure coincided with substantially greater male participation, although further gains are necessary.