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Biomedical subjects

P J Feldblum

Publications and source records attributed to P J Feldblum.

At least 19 recordsLinked to original sources
PubMed2005

Results of a randomised trial of male condom promotion among Madagascar sex workers.

OBJECTIVES: To test the effect of supplementing peer promotion of male condom use with clinic based counselling, measured in terms of STI prevalence and reported male condom use. METHODS: 1000 female sex workers in Madagascar were randomised to two study arms: peer education supplemented by individual risk reduction counselling by a clinician (peer + clinic) versus condom promotion by peer educators only (peer only). STI testing was conducted at baseline and 6 months. Behavioural interviews were administered at baseline, 2, 4, and 6 months. RESULTS: At baseline, women in the peer only arm had prevalences of 16.0%, 23.6%, and 12.1% for chlamydia, gonorrhoea, and trichomoniasis respectively, with an aggregate prevalence of 38.2%. Baseline STI prevalences for the peer + clinic arm were slightly lower and 34.1% in aggregate. At 6 months, aggregate STI prevalence increased in the peer only arm to 41.4%, whereas the aggregate prevalence diminished slightly to 32.1% in the peer + clinic arm. In logistic regression analyses, the estimated odds ratios (ORs) for chlamydia, gonorrhoea, trichomoniasis, and aggregate STI were 0.7 (95% confidence interval 0.4 to 1.0), 0.7 (0.5 to 1.0), 0.8 (0.6 to 1.2), and 0.7 (0.5 to 0.9) respectively, comparing the peer + clinic arm with the peer only arm. The logistic regression OR for reported condom use with clients in the past 30 days increased from 1.1 at 2 months to 1.8 at 6 months, comparing the peer + clinic arm with the peer only arm, and was 1.4 overall (1.1 to 1.8). Adjustment for baseline factors changed the regression results little. CONCLUSIONS: The impact of male condom promotion on behaviour can be heightened through more concentrated counselling on risk reduction. Persistently high STI prevalence despite increases in reported condom use by sex workers supports the need for multidimensional control programmes.

Chlamydia Infections↗
PubMed2001

Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya.

OBJECTIVE: To measure the impact on sexually transmitted infection (STI) prevalence of a female condom introduction and risk-reduction program at Kenyan agricultural sites. DESIGN: We conducted a cluster-randomized trial to determine whether a replicable, community-level intervention would reduce STI prevalence. METHODS: Six matched pairs of tea, coffee and flower plantations were identified. The six intervention sites received an information/motivation program with free distribution of female and male condoms, and six control sites received only male condoms and related information. Participants were tested for cervical gonorrhea and chlamydia by ligase chain reaction on urine specimens, and vaginal trichomoniasis by culture, at baseline, 6 and 12 months. RESULTS: Participants at intervention (n = 969) and control sites (n = 960) were similar; baseline STI prevalence was 23.9%. Consistent male condom use was more than 20% at 12 months. Consistent female condom use was reported by 11 and 7% of intervention site women at 6 and 12 months. Unadjusted STI prevalence was 16.5 and 17.4% at 6 months, and 18.3 and 18.5% at 12 months, at the intervention and control sites, respectively. Logistic regression models confirmed the null effect of the female condom intervention. CONCLUSIONS: Female condom introduction did not enhance STI prevention at these sites. It is unclear which aspects of the intervention -- STI education, condom promotion, case management -- were associated with decreased STI prevalence from baseline to follow-up.

Adult↗
PubMed2001

A comparison of three daily coital diary designs and a phone-in regimen.

Barrier contraceptive trials and disease intervention studies often utilize coital diaries to measure sexual exposures: dates and frequency of intercourse, product use, additional or alternative contraceptive use, and menstrual bleeding. The validity of these self-reported data is a matter of debate, but if used, better diary designs are sought. We studied 3 different coital diaries, plus a phone-in regimen (none or weekly) in a 3 x 2 factorial design to compare participant ratings and promptness of recording. Our underlying presumption was that ease of and satisfaction with use, and promptness of data collection, are associated with greater accuracy. A self-completed questionnaire at the end of the study collected comparative retrospective data. Diary 1 captured information about a single day on one page and had three columns, for up to three possible acts of intercourse. Diary 2 had the same question format as the first diary, but contained 7 days per page. Diary 3 had 7 days on a page, but instead of a column for each act, participants enumerated the number of acts, the types of contraception used, and condom use details. Half of the women in each diary group phoned in their data weekly. Phone-in improved participants' satisfaction with the diary design as reflected by higher ratings of diary features. Phone-in did not improve recall of data at the end of the study for any of the diaries. There were no differences in the promptness of diary completion. Diaries 1 and 2 showed good concordance with recalled data, and participants expressed a preference for the layout of Diary 2. Women assigned to Diary 3 expressed dissatisfaction with the design and were worse at recalling data at the end of the study, probably due to the complexity of that diary design.

Adolescent↗
PubMed2001

Condom use during a community intervention trial in Kenya.

We conducted a cluster-randomized community intervention trial at Kenyan agricultural sites to measure the impact of female condom introduction on sexually transmitted infection (STI) prevalence. We present male and female condom use data here. Six Intervention sites received a community risk-reduction campaign and distribution of female condoms and male condoms, while 6 Control sites received the same campaign with male condoms only. Male and female condom distribution increased throughout follow-up. Self-reported male condom use increased substantially during follow-up to over 60% of the participants. The proportion of consistent male condom users at Control sites was higher than at Intervention sites, 23% vs 14% at 6 months and 24% vs 22% at 12 months. At Intervention sites, 11% and 7% of women used the female condoms all the time at 6 and 12 months, respectively, while the percentage of female condom non-users grew. Male and female condom use was hindered by male partner objections; suspicion of the study and the devices among residents; and bias against condoms by clinic service providers. A large proportion of coital acts remained unprotected during the trial. Our female condom intervention did not reduce STI prevalence, compared with male condom promotion only.

Adult↗
PubMed2000

Pregnancy rates among Chilean women who had non-surgical sterilization with quinacrine pellets between 1977 and 1989.

We describe cumulative pregnancy probabilities among women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N = 1492). We interviewed the women or relatives in 1991-93 and 1994-96, and reviewed hospital records. Mean follow-up was 9.6 years (median 9 years). We recorded 120 pregnancies, including 40 that went to term or near-term. There were nine adverse outcomes in eight infants: one fetal death at 18 weeks gestation; three infants born prematurely; one stillbirth (placental infarct); and four infants with birth defects. There was no clustering of any particular kind of birth defect. For two insertions, the 10-year cumulative pregnancy probability was 8.9 (95% confidence interval 3. 7, 14.1). For 3 insertions, the 10-year rate was 7.0 (4.4, 9.5). For women who were under 35 years at insertion, the 10-year rate was 10. 7 (7.4, 14.1). For women who were 35 or older at insertion, the 10-year rate was 3.1 (0.6, 5.7). The pregnancy rate varied little for 2 vs. three insertions, but the rate did vary significantly by age, with women who received quinacrine at 35 years or older 0.3 (0. 2, 0.5) times as likely to become pregnant as younger women. The 10-year cumulative ectopic pregnancy probabilities for women with two and three insertions of quinacrine were 0.9 (<0.1, 2.6) and 0.5 (<0.1, 1.2), respectively. Pregnancy rates after quinacrine insertion are higher than after surgical sterilization, but ectopic pregnancy rates appear similar.

Adult↗
PubMed2000

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use.

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%--2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used. Thus, the prevented fraction due to condom use (effectiveness) is 100% and the lower bounds of the 95% CI are between 89% and 90%. For this cohort, male latex condoms were an effective method of contraception. This cost-efficient approach of evaluating contraceptive effectiveness shows promise for post-marketing studies.

Adult↗
PubMed2000

The female condom and STDs: design of a community intervention trial.

OBJECTIVES: The main purpose of this study is to compare sexually transmitted disease (STD) prevalence in cohorts of women with and without access to female condoms. METHODS: Six matched pairs of communities were identified from Kenya tea, coffee and flower plantations. One community within each pair was randomly selected to receive the female condom intervention. Approximately 160 eligible women were enrolled at each site. Female condom communities underwent an education program on use of female and male condoms and STDs, comprising group meetings, puppetry and other folk media, and training of clinic service providers and community outreach workers. Control communities received similar information on use of male condoms (freely available at all sites). At baseline, participants were tested for cervical gonorrhea and chlamydia and vaginal trichomoniasis, to be repeated at 6 and 12 months. The study has 80% power to detect a 10% prevalence difference, assuming an aggregate STD prevalence of 20% with 25% loss to follow-up and intracluster correlation of 0.03. RESULTS: Among 1929 women at baseline, the mean age was 33.1 years; 78% had never used a male condom. The prevalences of gonorrhea, chlamydia and trichomoniasis were 2.6%, 3. 2% and 20.4%, respectively (23.9% overall). The intracluster correlation based on these data was near zero. CONCLUSIONS: Comparable pairs of study sites have been selected. STD prevalence is sufficiently high, and the variation between sites is acceptably low. The study is feasible as designed.

Adolescent↗
PubMed2000

Baseline STD prevalence in a community intervention trial of the female condom in Kenya.

OBJECTIVE: We present baseline sexually transmitted disease (STD) prevalence rates from an ongoing intervention trial at Kenyan agricultural sites. METHODS: After gaining the cooperation of management, we identified six matched pairs of tea, coffee, and flower plantations and enrolled approximately 160 women at each site. Six intervention sites received an information programme and distributed female and male condoms, while six control sites received male condoms only and similar information about them. At clinic visits, we tested participants for cervical gonorrhoea (GC) and Chlamydia trachomatis (CT) by ligase chain reaction on urine specimens, and Trichomonas vaginalis (TV) by culture. The study has 80% power to detect a 10% prevalence difference during follow up, assuming a combined STD prevalence of 20%, 25% loss to follow up and intracluster correlation coefficient (ICC) of 0.03. RESULTS: Participants at intervention and control sites (total 1929) were similar at baseline. Mean age was 33 years, the majority were married, more than half currently used family planning, 78% had never used male condoms, and 9% reported more than one sexual partner in the 3 months before the study. Prevalences of GC, CT, and TV were 2.6%, 3.2%, and 20.4% respectively (23.9% overall), and were similar at intervention and control sites. The ICC for STD prevalence was 0.0011. Baseline STD was associated with unmarried status, non-use of family planning, alcohol use, and more than one recent sexual partner, but the highest odds ratio was 1.5. CONCLUSIONS: Baseline results confirm a high prevalence of trichomoniasis and bacterial STD at these Kenyan rural sites. Improved STD management is urgently needed there. Our ongoing female condom intervention trial is feasible as designed.

Adolescent↗
PubMed1999

Intrauterine devices. The optimal long-term contraceptive method?

OBJECTIVE: To review selected data on the effectiveness, safety, cost and technical ease of intrauterine device (IUD) use compared with Norplant and surgical sterilization. STUDY DESIGN: Literature review. RESULTS: IUDs are highly effective, safe and relatively inexpensive methods of contraception that may offer advantages for some women over other long-term methods, such as sterilization and Norplant. IUDs provide protection against pregnancy comparable to that provided by female sterilization, and they may be more effective than Norplant. IUDs have a long duration of effectiveness: the copper T 380A (TCu380A) is effective for at least 10 years, and the levonorgestrel (LNg) IUD appears to be effective for at least 7. Norplant is effective for only five years. Both types of IUD can disrupt menstrual bleeding patterns, although the patterns of bleeding are different. Copper IUDs often increase blood loss, whereas the LNg IUD, like Norplant, substantially reduces menstrual bleeding. The most important adverse outcome associated with IUD use is higher rates of pelvic inflammatory disease; careful attention to proper insertion techniques can reduce this risk substantially, and LNg IUDs may cause no increase in risk. IUDs, like both sterilization and Norplant, provide no protection against sexually transmitted disease. The TCu380A IUD is extremely cost-effective. There is as yet no public sector price for the LNg IUD, which has not been approved by the U.S. Food and Drug Administration and is not provided by family planning donor organizations. If it can be made available to the public sector at a price substantially less than its present market price, the LNg IUD would be a useful addition to the contraceptive armamentarium for developing countries. CONCLUSION: Providers, consumers and family planning program managers should begin to see IUDs as potential substitutes for both surgical sterilization and Norplant.

Contraceptive Agents, Female↗
PubMed1998

Female condom acceptability among sex workers in Costa Rica.

This study measured short-term female condom acceptability among 51 female sex workers in San José, Costa Rica. Each woman was trained in use of the female condom and was asked to use the device if clients refused to use male condoms during a 2-week study period (male condoms were also distributed). Two follow-up visits with short interviews were scheduled, including questions on general reaction to the female condom by the participants and their clients, ease and comfort of use, and preferences for male or female devices. At the first follow-up visit, 51% of the women reported they "liked the female condom very much" and 45% reported they "liked it somewhat." Similar results were reported after the second follow-up phase. Sixty-seven percent of the participants preferred the female condom over the male condom, and, according to the the women, over half of their clients liked the female condom "very much" or "somewhat." The most common problems during the first phase were difficulty to insert (61%) and discomfort (43%). However, during the second study phase a reduction in these problems (22% and 25%, respectively) and other use-related problems were noted. Although this new method is not yet available throughout Costa Rica, these results should encourage sexually transmitted diseases and HIV service organizations to make this method accessible to women.

Acquired Immunodeficiency Syndrome↗
PubMed1997

Condom and nonoxynol-9 use and the incidence of HIV infection in serodiscordant couples in Zambia.

We aimed to measure the effectiveness of latex condoms and of nonoxynol-9 [N-9] spermicides, in preventing HIV transmission in heterosexual serodiscordant couples in Lusaka. Each couple was examined at clinic visits scheduled at 3-month intervals for one year or more per couple, or until seroconversion or discontinuation. Couples were given condoms and their choice of 3 N-9 products and advised to use both at every intercourse. Sexual exposure was ascertained from coital logs that recorded coitus and barrier method use. HIV serological testing was done at each clinic visit (ELISA and Western blot if positive). One hundred and ten discordant couples were followed for a mean of 17.6 months. Seventy-eight per cent of coital episodes were protected by condoms, 85% by spermicides and 6.4% were unprotected. Fourteen seroconversions occurred (8.7 infections per 100 couple-years [c-y]). The rate was higher among seronegative men than seronegative women. Among couples who reported using condoms at every intercourse the infection rate was 2.3/100 c-y, compared with 10.7/100 c-y among couples using condoms less consistently (rate ratio [RR] 0.2; 95% confidence interval [CI] 0-1.6). Among couples who reported using N-9 at every intercourse, the seroconversion rate was 6.9/100 c-y; among couples who reported less than full-time N-9 use, the rate was 8.9/100 c-y (RR 0.8; 95% CI 0.2-2.8). Among the subset of female seronegatives, the N-9 RR was 0.5 (95% CI 0.1-3.8). But when we calculated HIV rates according to N-9 consistency in coital acts when condoms were not used, there was no evidence of protection with higher N-9 use. Consistent use of latex condoms reduces the incidence of HIV infection, but the association between N-9 spermicides and HIV is less clear. The current study could not provide compelling data on the impact of N-9 spermicide use on risk of HIV infection. The study's small size, as well as the consistency of concurrent condom use, limited our inferences. Available spermicide products must be studied further.

Adolescent↗
PubMed1995

Effectiveness of the non-spermicidal fit-free diaphragm.

Standard instructions for diaphragm use call for an individually sized latex diaphragm, used in conjunction with spermicide jelly. However, some investigators have reported that the diaphragm can be effective without a spermicide. A non-randomized trial designed to measure the contraceptive effectiveness of the diaphragm used without spermicide was conducted. A total of 110 self-selected women were enrolled to use a non-spermicide fit-free (60mm) diaphragm for a period of one year. They were advised to wear the diaphragm continuously, removing it once each day for washing but not within six hours after intercourse. Product-related problems related to insertion, retention and removal were few at both the 6- and 12-month follow-up visits, most commonly odor. The 12-month life table accidental pregnancy rate during typical use was 24.1 per 100 women (29.5 per 100 women without female barrier experience and 17.9 per 100 women with barrier experience). Over 85% of the women who returned for follow-up visits reported using the diaphragm during every act of intercourse. Until better data refute the traditional recommendations, users should be advised to add spermicide to fitted latex diaphragms.

Adult↗