Maria F Gallo

The Ohio State University, Columbus, Ohio, United States

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Publications (96)404.36 Total impact

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    ABSTRACT: Despite liberalization of the Nepal abortion law, young women continue to experience barriers to safe abortion services. We hypothesize that marital status may differentially impact such barriers, given the societal context of Nepal. We evaluated differences in reproductive knowledge and attitudes by marital status with a probability-based, cross-sectional survey of young women in Rupandehi district, Nepal. Participants (N = 600) were surveyed in 2012 on demographics, romantic experiences, media habits, reproductive information, and abortion knowledge and attitudes. We used logistic regression to assess differences by marital status, controlling for age. Participants, who comprised never-married (54%) and ever-married women (45%), reported good access to basic reproductive health and abortion information. Social desirability bias might have prevented reporting of premarital romantic and sexual activity given that participants reported more premarital activities for their friends than for themselves. Only 45% knew that abortion was legal, and fewer ever-married women were aware of abortion legality. Never-married women expected more negative responses from having an abortion than ever-married women. Findings highlight the need for providing sexual and reproductive health care information and services to young women regardless of marital status.
    BMC Women's Health 12/2015; 15(1). DOI:10.1186/s12905-015-0175-4 · 1.50 Impact Factor
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    ABSTRACT: To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception (LARC), reduces condom use, as measured by a biomarker of recent semen exposure (prostate-specific antigen (PSA)). We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a three-month study period. Participants were tested for PSA at baseline and two follow-up study visits, and asked about their sexual activity and condom use. At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm (1-month: 26.1% vs. 20.2%; prevalence ratio (PR) = 1.3; (95% confidence interval (CI) = 0.9-1.9); 3-month: 25.6% vs. 23.1%; PR= 1.1; (95% CI = 0.8-1.6)). The change in PSA positivity over the 3 study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value=0.15). Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short-term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant. Copyright © 2015. Published by Elsevier Inc.
    Contraception 06/2015; DOI:10.1016/j.contraception.2015.06.009 · 2.34 Impact Factor
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    ABSTRACT: Postpartum contraception improves the health of mothers and children by lengthening birth intervals. For lactating women, contraception choices are limited by concerns about hormonal effects on milk quality and quantity and passage of hormones to the infant. Ideally, the contraceptive chosen should not interfere with lactation or infant growth. Timing of contraception initiation is also important. Immediately postpartum, most women have contact with a health professional, but many do not return for follow-up contraceptive counseling. However, immediate initiation of hormonal methods may disrupt the onset of milk production. To determine the effects of hormonal contraceptives on lactation and infant growth SEARCH METHODS: We searched for eligible trials until 2 March 2015. Sources included the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, POPLINE, Web of Science, LILACS,, and ICTRP. We also examined review articles and contacted investigators. We sought randomized controlled trials in any language that compared hormonal contraception versus another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception includes combined or progestin-only oral contraceptives, injectable contraceptives, implants, and intrauterine devices.Trials had to have one of our primary outcomes: breast milk quantity or biochemical composition; lactation initiation, maintenance, or duration; infant growth; or timing of contraception initiation and effect on lactation. Secondary outcomes included contraceptive efficacy while breastfeeding and birth interval. For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% CI. Due to differing interventions and outcome measures, we did not aggregate the data in a meta-analysis. In 2014, we added seven trials for a new total of 11. Five reports were published before 1985 and six from 2005 to 2014. They included 1482 women. Four trials examined combined oral contraceptives (COCs), and three studied a levonorgestrel-releasing intrauterine system (LNG-IUS). We found two trials of progestin-only pills (POPs) and two of the etonogestrel-releasing implant. Older studies often lacked quantified results. Most trials did not report significant differences between the study arms in breastfeeding duration, breast milk composition, or infant growth. Exceptions were seen mainly in older studies with limited information.For breastfeeding duration, two of eight trials indicated a negative effect on lactation. A COC study reported a negative effect on lactation duration compared to placebo but did not quantify results. Another trial showed a lower percentage of the LNG-IUS group breastfeeding at 75 days versus the nonhormonal IUD group (reported P < 0.05) but no significant difference at one year.For breast milk volume, two older studies indicated lower volume for the COC group versus the placebo group. One trial did not quantify results. The other showed lower means (mL) for the COC group, e.g. at 16 weeks (MD -24.00, 95% CI -34.53 to -13.47) and at 24 weeks (MD -24.90, 95% CI -36.01 to -13.79). Another four trials did not report any significant difference between the study groups in milk volume or composition with two POPs, a COC, or the etonogestrel implant.Seven trials studied infant growth; one showed greater weight gain (grams) for the etonogestrel implant versus no method for six weeks (MD 426.00, 95% CI 58.94 to 793.06) but less compared with depot medroxyprogesterone acetate (DMPA) from 6 to 12 weeks (MD -271.00, 95% CI -355.10 to -186.90). The others studied POPs, COCs versus POPs, or an LNG-IUS. Results were not consistent across the 11 trials. The evidence was limited for any particular hormonal method. The quality of evidence was moderate overall and low for three of four placebo-controlled trials of COCs or POPs. The sensitivity analysis included six trials with moderate quality evidence and sufficient outcome data. Five trials indicated no significant difference between groups in breastfeeding duration (etonogestrel implant insertion times, COC versus POP, and LNG-IUS). For breast milk volume or composition, a COC study showed a negative effect, while an implant trial showed no significant difference. Of four trials that assessed infant growth, three indicated no significant difference between groups. One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA.
    Cochrane database of systematic reviews (Online) 03/2015; 3(3):CD003988. DOI:10.1002/14651858.CD003988.pub2 · 6.03 Impact Factor
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    ABSTRACT: We used data from a prospective study of 300 women attending a sexually transmitted infection clinic in Kingston, Jamaica, to compare participant self-report of recent semen exposure to actual semen exposure measured by prostate-specific antigen in vaginal swabs. Underreporting of semen exposure was significantly more frequent at follow-up than baseline, suggesting that the accuracy of reports of sexual behavior may vary over time. © 2015 by the American Sexually Transmitted Diseases Association.
    Sex Transm Dis 03/2015; 42(3):160-161. DOI:10.1097/OLQ.0000000000000243 · 2.84 Impact Factor
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    ABSTRACT: Background: Bacterial vaginosis (BV) is a perturbation of vaginal flora characterized by reduced levels of lactobacilli and concomitant overgrowth of anaerobic bacterial species. BV is highly prevalent and associated with multiple adverse outcomes, including enhanced human immunodeficiency virus transmission. Because recent reports reveal that herpes simplex virus type 2 (HSV-2) infection may increase BV risk, we initiated a systematic review and meta-analysis of the link between HSV-2 infection and BV. Methods: We searched the MEDLINE, EMBASE, and CENTRAL databases to identify articles posted before 1 December 2014. Two screeners independently reviewed the titles and abstracts of all identified articles, reviewed the full text of articles deemed potentially eligible, and extracted data from 14 cross-sectional and 3 prospective studies. Using random-effects models, we computed separate pooled estimates for cross-sectional and prospective studies. Results: The pooled odds ratio for cross-sectional studies was 1.60 (95% confidence interval, 1.32-1.94). Stronger support for the causal effect of HSV-2 infection on BV risk was revealed by the summary relative risk for the prospective studies, which was 1.55 (95% confidence interval, 1.30-1.84), with minimal heterogeneity (I(2) = 0). Conclusions: These analyses imply that HSV-2 infection is an important BV risk factor. Pharmacologic HSV-2 suppression may reduce BV incidence and BV-associated adverse events.
    The Journal of Infectious Diseases 01/2015; 212(1). DOI:10.1093/infdis/jiv017 · 6.00 Impact Factor
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    ABSTRACT: Objective: To better understand preferences and practices regarding partner notification of sexually transmitted infection (STI) among female, African-American adolescents. Methods: Participants completed a questionnaire and STI testing at baseline. Those diagnosed with Chlamydia or gonorrhea were recruited for a follow-up study, involving another questionnaire and repeat STI testing after three months. Results: At baseline, most participants (85.1%) preferred to tell their partner about an STI diagnosis themselves instead of having a health care provider inform him, and 71.0% preferred to bring their partner for clinic treatment instead of giving him pills or a prescription. Two-thirds of participants were classified as having high self-efficacy for partner notification of a positive STI diagnosis. In the multivariable analysis, older participants and those with fewer lifetime sexual partners were more likely to have high self-efficacy. Ninety-three participants (26.6%) had Chlamydia or gonorrhea and, of this subset, 55 participated in the follow-up study. Most adolescents in the follow-up study (76.4%) notified their partner about their infection. Conclusion: Although participants were willing to use most methods of partner notification, most preferred to tell partners themselves and few preferred expedited partner therapy. Traditional methods for partner notification and treatment may not be adequate for all adolescents in this population.
    Infectious Diseases in Obstetrics and Gynecology 12/2014; 2014:619632. DOI:10.1155/2014/619632
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    ABSTRACT: Objectives There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers PSA or Y chromosome DNA. Study Design We tested (in vitro) dilutions of tenofovir (TFV), UC781, and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction (real-time PCR). Results TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard, but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. Conclusions The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. Implications Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV and HEC.
    Contraception 08/2014; 90(2). DOI:10.1016/j.contraception.2014.03.009 · 2.34 Impact Factor
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    ABSTRACT: A biomarker of unprotected receptive anal intercourse could improve validity of sexual behavior measurement. We quantified prostate-specific antigen (PSA) from rectal swabs from men who have sex with men (MSM). One swab was PSA positive. Using current methods, PSA is an inadequate biomarker of recent unprotected receptive anal intercourse in men who have sex with men.
    Sexually transmitted diseases 06/2014; 41(6):377-9. DOI:10.1097/OLQ.0000000000000129 · 2.84 Impact Factor
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    ABSTRACT: Dual-method contraception refers to using condoms as well as another modern method of contraception. The latter (usually non-barrier) method is commonly hormonal (e.g., oral contraceptives) or a non-hormonal intrauterine device. Use of two methods can better prevent pregnancy and the transmission of HIV and other sexually transmitted infections (STIs) compared to single-method use. Unprotected sex increases risk for disease, disability, and mortality in many areas due to the prevalence and incidence of HIV/STI. Millions of women, especially in lower-resource areas, also have an unmet need for protection against unintended pregnancy. We examined comparative studies of behavioral interventions for improving use of dual methods of contraception. Dual-method use refers to using condoms as well as another modern contraceptive method. Our intent was to identify effective interventions for preventing pregnancy as well as HIV/STI transmission. Through January 2014, we searched MEDLINE, CENTRAL, POPLINE, EMBASE, COPAC, and Open Grey. In addition, we searched and ICTRP for current trials and trials with relevant data or reports. We examined reference lists of pertinent papers, including review articles, for additional reports. Studies could be either randomized or non-randomized. They examined a behavioral intervention with an educational or counseling component to encourage or improve the use of dual methods, i.e., condoms and another modern contraceptive. The intervention had to address preventing pregnancy as well as the transmission of HIV/STI. The program or service could be targeted to individuals, couples, or communities. The comparison condition could be another behavioral intervention to improve contraceptive use, usual care, other health education, or no intervention.Studies had to report use of dual methods, i.e., condoms plus another modern contraceptive method. We focused on the investigator's assessment of consistent dual-method use or use at last sex. Outcomes had to be measured at least three months after the behavioral intervention began. Two authors evaluated abstracts for eligibility and extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Where studies used adjusted analysis, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures. We identified four studies that met the inclusion criteria: three randomized controlled trials and a pilot study for one of the included trials. The interventions differed markedly: computer-delivered, individually tailored sessions; phone counseling added to clinic counseling; and case management plus a peer-leadership program. The latter study, which addressed multiple risks, showed an effect on contraceptive use. Compared to the control group, the intervention group was more likely to report consistent dual-method use, i.e., oral contraceptives and condoms. The reported relative risk was 1.58 at 12 months (95% CI 1.03 to 2.43) and 1.36 at 24 months (95% CI 1.01 to 1.85). The related pilot study showed more reporting of consistent dual-method use for the intervention group compared to the control group (reported P value = 0.06); the investigators used a higher alpha (P < 0.10) for this pilot study. The other two trials did not show any significant difference between the study groups in reported dual-method use or in test results for pregnancy or STIs at 12 or 24 months. We found few behavioral interventions for improving dual-method contraceptive use and little evidence of effectiveness. A multifaceted program showed some effect but only had self-reported outcomes. Two trials were more applicable to clinical settings and had objective outcomes measures, but neither showed any effect. The included studies had adequate information on intervention fidelity and sufficient follow-up periods for change to occur. However, the overall quality of evidence was considered low. Two trials had design limitations and two had high losses to follow up, as often occurs in contraceptive trials. Good quality studies are still needed of carefully designed and implemented programs or services.
    Cochrane database of systematic reviews (Online) 03/2014; 3(3):CD010915. DOI:10.1002/14651858.CD010915.pub2 · 6.03 Impact Factor
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    ABSTRACT: The advent of fertility treatments has led to an increase in the rate of multiple births in the United States. However, the trends in and magnitude of the contribution of fertility treatments to the increase are uncertain. We derived the rates of multiple births after natural conception from data on distributions of all births from 1962 through 1966 (before fertility treatments were available). Publicly available data on births from 1971 through 2011 were used to determine national multiple birth rates, and data on in vitro fertilization (IVF) from 1997 through 2011 were used to estimate the annual proportion of multiple births that were attributable to IVF and to non-IVF fertility treatments, after adjustment for maternal age. Trends in multiple births were examined starting from 1998, the year when clinical practice guidelines for IVF were developed with an aim toward reducing the incidence of multiple births. We estimated that by 2011, a total of 36% of twin births and 77% of triplet and higher-order births resulted from conception assisted by fertility treatments. The observed incidence of twin births increased by a factor of 1.9 from 1971 to 2009. The incidence of triplet and higher-order births increased by a factor of 6.7 from 1971 to 1998 and decreased by 29% from 1998 to 2011. This decrease coincided with a 70% reduction in the transfer of three or more embryos during IVF (P<0.001) and a 33% decrease in the proportion of triplet and higher-order births attributable to IVF (P<0.001). Over the past four decades, the increased use of fertility treatments in the United States has been associated with a substantial rise in the rate of multiple births. The rate of triplet and higher-order births has declined over the past decade in the context of a reduction in the transfer of three or more embryos during IVF. (Funded by the Centers for Disease Control and Prevention.).
    New England Journal of Medicine 12/2013; 369(23):2218-25. DOI:10.1056/NEJMoa1301467 · 55.87 Impact Factor
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    ABSTRACT: Although common worldwide, intravaginal cleansing is associated with poor health outcomes. We sought to describe intravaginal cleansing among women attending a sexually transmitted infection (STI) clinic in Jamaica. We examined intravaginal cleansing ("washing up inside the vagina", douching, and products or materials used) among 293 participants in a randomized trial of counselling messages at an STI clinic in Kingston. We focussed on information on intravaginal cleansing performed in the 30 days and three days preceding their baseline study visit. We describe reported cleansing behaviours and used logistic regression to identify correlates of intravaginal cleansing. Fifty-eight per cent of participants reported intravaginal cleansing in the previous 30 days, and 46% did so in the three days before baseline. Among those who cleansed in the previous 30 days, 88% reported doing so for hygiene unrelated to sex, and three-fourths reported generally doing so more than once per day. Soap (usually with water) and water alone were the most common products used for washing; commercial douches or detergents were reported infrequently. Intravaginal cleansing in the three days before the baseline visit was positively associated with having more than one sex partner in the previous three months (adjusted odds ratio [AOR], 1.9; 95% CI, 1.1, 3.2), and negatively associated with experiencing itching in the genital area at baseline (AOR, 0.6; 95% CI, 0.4, 1.0). A large proportion of women attending STI clinics in Jamaica engage in frequent intravaginal cleansing, indicating a need for clinicians to discuss this topic with them accordingly.
    The West Indian medical journal 10/2013; 62(1):56-61. · 0.33 Impact Factor
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    ABSTRACT: Unprotected sex is a major risk factor for disease, disability, and mortality in many areas of the world due to the prevalence and incidence of sexually transmitted infections (STI) including HIV. The male condom is one of the oldest contraceptive methods and the earliest method for preventing the spread of HIV. When used correctly and consistently, condoms can provide dual protection, i.e., against both pregnancy and HIV/STI. We examined comparative studies of behavioral interventions for improving condom use. We were interested in identifying interventions associated with effective condom use as measured with biological assessments, which can provide objective evidence of protection. Through September 2013, we searched computerized databases for comparative studies of behavioral interventions for improving condom use: MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, OpenGrey, COPAC,, and ICTRP. We wrote to investigators for missing data. Studies could be either randomized or nonrandomized. They examined a behavioral intervention for improving condom use. The comparison could be another behavioral intervention, usual care, or no intervention. The experimental intervention had an educational or counseling component to encourage or improve condom use. It addressed preventing pregnancy as well as the transmission of HIV/STI. The focus could be on male or female condoms and targeted to individuals, couples, or communities. Potential participants included heterosexual women and heterosexual men.Studies had to provide data from test results or records on a biological outcome: pregnancy, HIV/STI, or presence of semen as assessed with a biological marker, e.g., prostate-specific antigen. We did not include self-reported data on protected or unprotected sex, due to the limitations of recall and social desirability bias. Outcomes were measured at least three months after the behavioral intervention started. Two authors evaluated abstracts for eligibility and extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures. Seven studies met our eligibility criteria. All were randomized controlled trials; six assigned clusters and one randomized individuals. Sample sizes for the cluster-randomized trials ranged from 2157 to 15,614; the number of clusters ranged from 18 to 70. Four trials took place in African countries, two in the USA, and one in England. Three were based mainly in schools, two were in community settings, one took place during military training, and one was clinic-based.Five studies provided data on pregnancy, either from pregnancy tests or national records of abortions and live births. Four trials assessed the incidence or prevalence of HIV and HSV-2. Three trials examined other STI. The trials showed or reported no significant difference between study groups for pregnancy or HIV, but favorable effects were evident for some STI. Two showed a lower incidence of HSV-2 for the behavioral-intervention group compared to the usual-care group, with reported adjusted rate ratios (ARR) of 0.65 (95% CI 0.43 to 0.97) and 0.67 (95% CI 0.47 to 0.97), while HIV did not differ significantly. One also reported lower syphilis incidence and gonorrhea prevalence for the behavioral intervention plus STI management compared to the usual-care group. The reported ARR were 0.58 (95% CI 0.35 to 0.96) and 0.28 (95% CI 0.11 to 0.70), respectively. Another study reported a negative effect on gonorrhea for young women in the intervention group versus the control group (ARR 1.93; 95% CI 1.01 to 3.71). The difference occurred among those with only one year of the intervention. We found few studies and little clinical evidence of effectiveness for interventions promoting condom use for dual protection. We did not find favorable results for pregnancy or HIV, and only found some for other STI. The overall quality of evidence was moderate to low; losses to follow up were high. Effective interventions for improving condom use are needed to prevent pregnancy and HIV/STI transmission. Interventions should be feasible for resource-limited settings and tested using valid and reliable outcome measures.
    Cochrane database of systematic reviews (Online) 10/2013; 10(10):CD010662. DOI:10.1002/14651858.CD010662.pub2 · 6.03 Impact Factor
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    The Lancet Global Health 09/2013; 1(3):e119-e120. DOI:10.1016/S2214-109X(13)70070-6 · 10.04 Impact Factor
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    ABSTRACT: Although biological markers of women's exposure to semen from vaginal intercourse have been developed as surrogates for risk of infection or probability of pregnancy, data on their persistence time and clearance are limited. During 2006-2008, 52 couples were enrolled for three 14-day cycles of abstinence from vaginal sex during which women were exposed in the clinic to a specific quantity (10, 100 or 1000 μL) of their partner's semen. Vaginal swabs were collected before and at 1, 6, 12, 24, 48, 72 and 144 h after exposure for testing for prostate-specific antigen (PSA) and Y-chromosome DNA (Yc DNA). Immediately after exposure to 1000 μL of semen, the predicted sensitivity of being PSA positive was 0.96; this decreased to 0.65, 0.44, 0.21 and 0.07 at 6, 12, 24 and 48 h, respectively. Corresponding predicted sensitivity of being Yc DNA positive was 0.72 immediately postexposure; this increased to 0.76 at 1 h postexposure and then decreased to 0.60 (at 6 h), 0.63 (at 12 h), 0.49 (at 24 h), 0.21 (at 48 h), 0.17 (at 72 h) and 0.12 (at 144 h). Overall findings suggest that PSA may be more consistent as a marker of very recent exposure and that Yc DNA is more likely to be detected in the vagina after 12 h postexposure compared to PSA.
    Contraception 08/2013; 88(6). DOI:10.1016/j.contraception.2013.08.003 · 2.34 Impact Factor
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    ABSTRACT: Madagascar recently scaled up their volunteer community health worker (CHW) program in maternal health and family planning to reach remote and underserved communities. We conducted a cross-sectional evaluation using a systematic sample of 100 CHWs trained to provide contraceptive counseling and short-acting contraceptive services at the community level. CHWs were interviewed on demographics, recruitment, training, supervision, commodity supply, and other measures of program functionality; tested on knowledge of injectable contraception; and observed by an expert while completing five simulated client encounters with uninstructed volunteers. We developed a CHW performance score (0-100%) based on the number of counseling activities adequately met during the client encounters and used multivariable linear regression to identify correlates of the score. CHWs had a mean performance score of 73.9% (95% confidence interval [CI]: 70.3-77.6%). More education, more weekly volunteer hours, and receiving a refresher training correlated with a higher performance score. We found no other associations between measures of the components previously identified as essential for effective CHW programs and performance score. Although areas of deficiency were identified, CHWs proved capable of providing high-quality contraception services.
    Contraception 06/2013; 88(5). DOI:10.1016/j.contraception.2013.06.008 · 2.34 Impact Factor
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    ABSTRACT: Research on interventions to prevent HIV and other sexually transmitted infections (STIs) is heavily influenced by participant reporting of sexual behavior, despite uncertainty about its validity. Exclusive reliance on participant self-report often is based, overtly or by implication, on 4 assumptions: (1) no feasible alternatives exist; (2) misreporting can be minimized to levels that can be disregarded; (3) misreporting tends to underreport sensitive behaviors; and (4) misreporting tends to be nondifferential with respect to the groups being compared. The objective of this review are to evaluate these assumptions, including a review of studies using semen biomarkers to evaluate the validity of self-reported data, and to make recommendations for applying biological markers of semen exposure detectable in women to further strengthen research on HIV/STI prevention. Increasing evidence shows that semen biomarkers provide an important means of assessing and augmenting the validity of studies on HIV/STI prevention. Additional biomarkers are needed to assess male exposure to vaginal sex and both male and female exposure to anal sex. Methods and study designs that incorporate biomarkers into studies collecting self-reported behavioral data should be considered where possible.
    Sexually transmitted diseases 06/2013; 40(6):447-52. DOI:10.1097/OLQ.0b013e31828b2f77 · 2.84 Impact Factor
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    ABSTRACT: Background: The effectiveness of counseling messages to avoid unprotected sex during short-term treatment for curable sexually transmitted infections is unknown. Methods: We randomized 300 female STI clinic patients 18 years or older with cervicitis and/or vaginal discharge in Kingston, Jamaica, in 2010 to 2011, to 1 of 2 counseling messages for their course of syndromic treatment: abstinence only or abstinence backed up by condom use. At a follow-up visit 6 days afterward, we collected vaginal swabs to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure, and administered a questionnaire assessing sexual behavior. Results: No differences were found in the proportions of women testing positive for PSA at follow-up in the abstinence-plus-condom group (11.9%) and abstinence-only group (8.4%) (risk difference, 3.5; 95% confidence interval, -3.5 to 10.5). There also was no significant difference in reporting of unprotected sex between groups. Reporting a history of condom use before enrollment significantly modified the effect of counseling arm on PSA positivity (P = 0.03). Among those reporting recent condom use, 10.3% in the abstinence-only arm and 4.8% in the abstinence-plus-condom arm tested positive for PSA. Conversely, among those not reporting recent condom use, 6.5% in the abstinence-only arm and 17.3% in the abstinence-plus-condom arm had PSA detected. Conclusions: We found no evidence to support the superiority of either counseling message. Post hoc analyses suggest that women with recent condom experience may benefit significantly more from abstinence-plus-condom messages, whereas women without such experience may benefit significantly more from abstinence-only messages. Providers should weigh individual condom use history when determining the most appropriate counseling message.
    Sexually transmitted diseases 02/2013; 40(2):105-110. DOI:10.1097/OLQ.0b013e31827938a1 · 2.84 Impact Factor
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    ABSTRACT: Background: Prostate-specific antigen (PSA) is a biomarker of recent semen exposure. There is currently only limited information on whether topical vaginal products affect PSA assays. We investigated this question using various dilutions of several vaginal products (lubricants and spermicides) and the Abacus ABAcard for PSA detection. Study design: Pooled semen controls and various dilutions of nonoxynol-9 (N9), carboxymethyl cellulose (CMC), Replens, Gynol 2, K-Y jelly, Astroglide, Surgilube, combined with pooled semen dilutions, were tested for PSA using the Abacus ABAcard. Results: N9 (2% with saline) and CMC did not appear to affect the results of testing with the ABAcard, but not all semen dilutions were tested. The other products (including Replens and Gynol, which is 2% N9 with propylene glycol, K-Y, Astroglide and Surgilube) at some of the dilutions tested either affected or gave invalid results with PSA testing using the ABAcard. Both Gynol 2 and K-Y at 1:10 dilution gave false-positive results. Conclusions: Some vaginal products affect PSA results obtained by using the semiquantitative ABAcard. In vivo confirmation is necessary to further optimize PSA detection when topical vaginal products are present.
    Contraception 12/2012; 88(3). DOI:10.1016/j.contraception.2012.10.034 · 2.34 Impact Factor
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    ABSTRACT: Background: Prostate-specific antigen (PSA) detected in vaginal fluid can be used in studies of HIV/sexually transmitted infection (STI) and pregnancy prevention as an alternative to relying on participant reports of exposure to semen. Optimal methods for collecting and storing specimens for this testing have not been determined. Study design: We conducted a controlled, in vitro experiment of 550 specimens spiked with semen to determine the effects of swab type (five types), storage conditions of the swabs (room temperature with or without desiccant or at -80°C without desiccant) and time from collection to testing (seven intervals over the course of 12 months) on the identification of PSA. We performed factorial analysis of variance to identify factors influencing PSA detection. Results: Concentrations of PSA detected in the swabs declined with time of storage over the 1-year experiment (p<.01). The 1-mL, rayon-tipped swab stored immediately at -80°C following collection performed best. Conclusions: If immediate testing or freezer storage is not feasible, investigators should use a swab with 1-mL capacity with processing and testing as soon as possible after specimen collection.
    Contraception 10/2012; 87(6). DOI:10.1016/j.contraception.2012.09.033 · 2.34 Impact Factor
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    ABSTRACT: Studies that evaluate condom effectiveness are affected by factors related to how the condom was used, and these factors may not be consistent between different types of condoms. Also, subjective assessments of the sexual act may be unreliable. We performed a secondary data analysis of a randomized crossover trial of male and female condoms among 108 couples. Self-reported duration and activeness of coital acts were significantly different for uses of the male condom compared to uses of the female condom. Fewer individuals reported ejaculation occurring with the female condom. Reliability of self-reports of ejaculation compared to a biological marker of semen detected inside the used male and female condoms was not strong. We found that sexual behaviors appear to differ by the type of condom used for the coital act. Studies should consider sexual behavior when evaluating condom effectiveness. Furthermore, studies would be strengthened by the use of a biological marker of semen to determine whether ejaculation, and therefore a true risk of exposure, occurred.
    Contraception 03/2012; 86(4):391-6. DOI:10.1016/j.contraception.2012.01.016 · 2.34 Impact Factor

Publication Stats

2k Citations
404.36 Total Impact Points


  • 2005–2015
    • The Ohio State University
      • Division of Epidemiology
      Columbus, Ohio, United States
  • 2009–2013
    • Centers for Disease Control and Prevention
      • Division of Reproductive Health
      Atlanta, Michigan, United States
  • 2005–2013
    • University of North Carolina at Chapel Hill
      • Department of Medicine
      North Carolina, United States
  • 2005–2006
    • IPAS
      North Carolina, United States
  • 2004
    • Canterbury District Health Board
      • Christchurch Hospital
      Christchurch, Canterbury Region, New Zealand
    • University of Otago
      • Department of General Practice & Rural Health
      Dunedin, Otago, New Zealand