Vaginal distribution of Replens and K-Y Jelly using three imaging techniques.

BACKGROUND: Determination of vaginal distribution is important to the development of potential vaginal microbicidal or spermicidal products. STUDY DESIGN: This was a descriptive study of three imaging techniques with a randomized crossover assignment of two gels and activity status within each technique. METHOD: Each of three sites utilized one technique. Three nulligravid women and three parous women were to be enrolled at each site. We studied the effects of time, ambulation, parity and body mass index on vaginal spreading of two commonly used gels, K-Y Jelly and Replens. Imaging by magnetic resonance imaging and gamma scintigraphy was performed at 5, 20, 35 and 50 min after insertion of 3.5 mL of gel. Imaging with a fiberoptic probe was performed at 5 and 20 min after insertion. RESULTS: Initial application of the gel resulted in approximately two thirds of maximum coverage possible, both in linear extent along the vaginal axis and in surface area covered. Over the next 45 min, spreading increased to about three quarters of the maximum possible. Ambulation generally increased linear spreading and the proportions of women with gel at the introitus and os. Effects of parity and body mass index (BMI) were similar on most measures of gel spreading, with nulligravid women tending toward greater spread than parous women and women of high BMI usually showing somewhat greater spread than women of normal weight. Differences between the two gels were not seen when all conditions of application were considered together. CONCLUSION: In vivo imaging of gel distribution demonstrated that ambulation, parity and BMI affect vaginal gel spreading. The three imaging techniques have advantages and disadvantages and provide complementary information for microbicide development.

Effectiveness of training supervisors to improve reproductive health quality of care: a cluster-randomized trial in Kenya.

Health facility supervisors are in a position to increase motivation, manage resources, facilitate communication, increase accountability and conduct outreach. This study evaluated the effectiveness of a training intervention for on-site, in-charge reproductive health supervisors in Kenya using an experimental design with pre- and post-test measures in 60 health facilities. Cost information and data from supervisors, providers, clients and facilities were collected. Regression models with the generalized estimating equation approach were used to test differences between study groups and over time, accounting for clustering and matching. Total accounting costs per person trained were calculated. The intervention resulted in significant improvements in quality of care at the supervisor, provider and client-provider interaction levels. Indicators of improvements in the facility environment and client satisfaction were not apparent. The costs of delivering the supervision training intervention totalled US$2113 per supervisor trained. In making decisions about whether to expand the intervention, the costs of this intervention should be compared with other interventions designed to improve quality.

Pregnancy among sex workers participating in a condom intervention trial highlights the need for dual protection.

BACKGROUND: Little is known about pregnancy rates among sex workers (SWs) or the factors that predispose SWs to this risk. We aimed to estimate the pregnancy incidence rate among Madagascar SWs participating in an intervention trial promoting use of male and female condoms and assess the influence of various predictive factors on pregnancy risk. METHODS: SWs from two study clinics in Madagascar participated in a randomized trial to assess the effect of peer education and clinic-based counseling on use of male and female condoms and prevalence of sexually transmitted infections (STIs). Women were seen every 2 months for up to 18 months; they received structured interviews at every visit, and physical exams at baseline and every 6 months thereafter. Site staff recorded information on pregnancies during interviews; pregnancy data were then merged with trial data for this analysis. RESULTS: Of 935 SWs in the analysis population, 250 became pregnant during follow-up. The cumulative probability of pregnancy was 0.149 at 6 months and 0.227 at 12 months. Comparable proportions of nonpregnant and pregnant SWs reported using highly effective contraception at baseline (approximately 16%); these users were younger and were more consistent condom users. Method switching and discontinuation were frequent. In multivariate analysis, nonuse of effective contraceptives and any self-reported unprotected sex were associated with higher incidence of pregnancy. Approximately 51% of women delivered, 13% reported a spontaneous abortion, 13% reported an induced abortion and 23% had missing pregnancy outcomes. CONCLUSIONS: Women traditionally targeted for STI/HIV preventive interventions need more comprehensive reproductive health services. In particular, SWs could benefit from targeted family planning counseling and services.

Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar.

OBJECTIVES: To assess whether individual clinic-based counselling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion. METHODS: In two public dispensaries in Madagascar, a total of 901 sex workers were randomly allocated between two alternative male and female condom promotion INTERVENTIONS: peer education only, or peer education supplemented with individual clinic-based counselling. Participants were followed for 12 months. Every 2 months they made clinic visits, where they were interviewed on condom use. Peer educators counselled all participants on condom use as they accompanied their assigned participants to study visits. Participants assigned to receive the supplemental intervention were counselled by a trained clinician following study interviews. Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis every 6 months. We used logistic regression to assess whether the more intensive intervention was associated with reduced STI prevalence. Use of protection with clients and non-paying partners was assessed by study arm, site, and visit. RESULTS: There was no statistically significant association between study arm and aggregated STI prevalence. No substantial differences in levels of reported protection were noted between study groups. CONCLUSIONS: This study found little evidence for gains from more thorough clinical counselling on male and female condom use. These findings suggest that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.

Increased risk of chlamydial and gonococcal infection in adolescent sex workers in Madagascar.

GOAL: To examine and compare young sex workers' risk of acquisition of sexually transmitted infections (STIs) with the risk among their older counterparts. OBJECTIVE: To evaluate the effect of young age--16-19 years vs. 20 years and older--on risk of incident infection with Neisseria gonorrhoeae (GC) or Chlamydia trachomatis (CT). STUDY DESIGN: A randomized controlled trial of 1,000 sex workers in Madagascar was conducted. STI testing was conducted at baseline, 6, 12, and 18 months. RESULTS: About 13% of the cohort (n = 134) was composed of young women aged 16-19 years. STI incidence rates in this group over the 18-month study period were high: 51.9/100 woman-years (WY) for GC and 47.4/100 WY for CT compared to 27.4/100 WY and 19.1/100 WY for sex workers over age 20, respectively. In multivariable models, young sex workers were at significantly higher STI risk compared with their older peers: The adjusted risk ratio (aRR) for GC comparing younger to older women was 1.50 (95% confidence interval (CI): 1.20, 1.88); for CT, the aRR was 1.72 (95% CI: 1.35, 2.19) and for GC or CT combined, the aRR was 1.42 (95% CI: 1.22, 1.66). CONCLUSIONS: This exploratory analysis suggests that additional research is warranted to identify effective and acceptable prevention strategies that benefit young women, and interventions already proven effective among adolescents should be given high priority for scale-up.

Does assessment of signs and symptoms add to the predictive value of an algorithm to rule out pregnancy?

BACKGROUND: A World Health Organization-endorsed algorithm, widely published in international guidance documents and distributed in the form of a 'pregnancy checklist', has become a popular tool for ruling out pregnancy among family planning clients in developing countries. The algorithm consists of six criteria excluding pregnancy, all conditional upon a seventh 'master criterion' relating to signs or symptoms of pregnancy. Few data exist on the specificity to pregnancy among family planning clients of long-accepted signs and symptoms of pregnancy. The aim of the present study was to assess whether reported signs and symptoms of pregnancy add to the predictive value of an algorithm to rule out pregnancy. METHODS: Data from a previous observational study were used to assess the performance of the algorithm with and without the 'signs and symptoms' criterion. The study group comprised 1852 new, non-menstruating family planning clients from seven clinics in Kenya. RESULTS: Signs and symptoms of pregnancy were rare (1.5%) as was pregnancy (1%). Signs and symptoms were more common (18.2%) among the 22 clients who tested positive for pregnancy than among the 1830 clients (1.3%) who tested negative, but did not add significantly to the predictive value of the algorithm. Most women with signs or symptoms were not pregnant and would have been unnecessarily denied a contraceptive method using the current criteria. CONCLUSIONS: The 'signs and symptoms' criterion did not substantially improve the ability of the algorithm to exclude pregnant clients, but several reasons (including use of the algorithm for intrauterine device clients) render it unlikely that the algorithm will be changed.

Comparative acceptability of combined and progestin-only injectable contraceptives in Kenya.

OBJECTIVE: We compared 12-month continuation rates, menstrual bleeding patterns and other aspects of acceptability between users of Cyclofem and users of Depo-Provera. METHODS: The life-table method was used to calculate quarterly continuation rates. In all, 360 Kenyan women were randomly assigned to one of the two contraceptives. User-satisfaction questionnaires were administered at 6 and 12 months or at discontinuation, whichever occurred first. RESULTS: The 1-year continuation rate was 75.4% for Depo-Provera users versus 56.5% for Cyclofem users (p<.001). Main reasons for discontinuation included difficulty making clinic visits (45.1% for Cyclofem vs. 40% for Depo-Provera), menstrual changes (14.1% vs. 12.5%) and nonmenstrual problems (15.5% vs. 12.5%). None of the Depo-Provera users and 8.5% of the Cyclofem users claimed frequency of visits as the main reason for discontinuation. In all, 70.6% of the Depo-Provera users were amenorrheic after 12 months, as were 20.8% of the Cyclofem users. CONCLUSIONS: The 1-year continuation rate was higher for Depo-Provera than for Cyclofem. There was no important difference in discontinuation rates because of menstrual problems; the difference mainly reflected the frequency of visits required.

Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL).

This was a blinded crossover study to determine the in vivo distribution of 2.5 and 3.5 mL of 6% cellulose sulfate gel. This potential vaginal microbicide was mixed with dilute gadolinium chelate and inserted into the vagina. Magnetic resonance imaging was performed at baseline and repeated after 5, 20, 35 and 50 min with subjects either resting or ambulating between data acquisitions. Use of 2.5 mL with no ambulation gave low linear spread (53.1% of vaginal length) and surface contact (61.7%) at 50 min. Using 3.5 mL of gel with ambulation improved linear spread (84.5%) and surface contact (85.9%) of the gel in the same time interval without significant leakage. Most linear spreading took place in the first 5 min after insertion, although lateral spreading continued to increase with time especially when ambulation took place. Leakage and gel was not a significant problem at either volume.

Effectiveness and complications associated with 2 vasectomy occlusion techniques.

PURPOSE: We compared the effectiveness and complications associated with 2 common vasectomy occlusion techniques, namely clipping and excision of a small vas segment and thermal cautery with fascial interposition and an open testicular end. MATERIALS AND METHODS: We retrospectively reviewed the computerized records of 3,761 men who underwent initial vasectomy at a single university hospital family planning clinic and at 2 private clinics in the Quebec City, Canada area, including concurrent and historical controls. All procedures were performed by 1 surgeon, who used the scalpel-free technique to expose the vas. RESULTS: The risk of vas occlusion failure in men with at least 1 semen analysis was much greater in the clipping and excision group than in the cautery, interposition and open testicular end group (126 of 1,453 or 8.7% versus 3 of 1,165 or 0.3%, OR 37, 95% CI 12 to 116). Medical consultations for hematoma or infection were more frequent in the cautery group (28 of 1,721 cases or 1.6% versus 10 of 2,040 or 0.5%, OR 3.4, 95% CI 1.6 to 6.9). Consultations for noninfectious pain were similar for the 2 techniques (71 of 1,721 cases or 4.1% versus 72 of 2,040 or 3.5%, OR 1.2, 95% CI 0.8 to 1.6). CONCLUSIONS: Cautery and interposition with an open testicular end are much more effective than clipping and excision. The effectiveness and morbidity associated with the components of the cautery, interposition and open testicular end technique need further evaluation.