Performance of Sino-implant (II) in routine service delivery in Madagascar.

BACKGROUND: Sino-implant (II) is a low-cost subdermal contraceptive implant containing levonorgestrel that is currently labeled for 4 years of use. Widely used in China and Indonesia, it has been little studied elsewhere. We conducted a prospective study of Sino-implant (II) use by women in Madagascar. METHODS: We enrolled a total of 621 women 18 or older who had Sino-implant (II) inserted on day of enrollment, some in fixed clinical sites, and some at outreach sites. Half of the women were scheduled for follow-up visits at 3 months and at 12 months postinsertion (active follow-up cohort); the other half were advised to return if they desired care for any problem, thought they were pregnant or wanted the implants removed (passive surveillance cohort). RESULTS: No insertion complications were reported. A total of 384 women returned for an earlier visit, and 351 returned for a later visit, for a total of 419 woman-years of observation. No postinsertion pregnancies or serious adverse events were observed. Twenty-eight implant removals were reported by 12 months, a cumulative removal probability of 7.3 per 100 women. Acceptability of the implants was very high, as was satisfaction with clinic services. CONCLUSIONS: This is the first report on the performance of Sino-implant (II) from outside China and Indonesia and among the first in the English-language literature. These initial data from Madagascar indicate a favorable level of safety, effectiveness and acceptability during the first year of use.

Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers.

We followed 1000 sex workers in Madagascar for 18 months to assess whether adding female condoms to male condom distribution led to increased protection levels and decreased sexually transmitted infections (STIs). For months 1-6, participants had access to male condoms only; in the final 12 months, they had access to male and female condoms. We interviewed participants about condom use every two months and tested for chlamydia, gonorrhoea and trichomoniasis every six months. Following six months of male condom distribution, participants used protection in 78% of sex acts with clients. Following female condom introduction, protection at months 12 and 18 rose to 83% and 88%, respectively. Aggregate STI prevalence declined from 52% at baseline to 50% at month 6. With the female condom added, STI prevalence dropped to 41% and 40% at months 12 and 18, respectively. We conclude female condom introduction is associated with increased use of protection to levels that reduce STI risk.

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.

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.

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.

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.

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.

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.

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.

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.

Intracluster correlation of STD prevalence in a community intervention trial in Kenya.

This study is a cluster-randomised, community intervention trial to measure the impact of female condom introduction on STD prevalence among Kenyan agricultural workers. The intracluster correlation coefficient of baseline STD prevalences at the 12 sites was 0.0011.

PIP: A cluster-randomized, community intervention trial to measure the impact of female condom introduction on sexually transmitted disease (STD) prevalence was conducted among Kenyan agricultural workers. The intracluster correlation coefficient (ICC) was used to measure the degree of homogeneity within clusters in comparison to total variability. The women in the sample population received condoms and were exposed to an STD prevention program through group meetings, video presentations, puppetry, and other folk media. They were also screened and tested for gonorrhea, chlamydia, and vaginal trichomoniasis. Tests were repeated after 6 and 12 months. The ICC of baseline STD prevalence at the 12 sites was 0.0011, and the proportion of women with STDs was higher at the control sites, which indicates a negligible clustering effect.

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.

PIP: This study reviews literatures on the effectiveness, safety, cost and technical ease of IUD use as compared with Norplant and surgical sterilization. Findings revealed that 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 is effective for at least 10 years, and the levonorgestrel (LNG) IUD seems to be effective for at least 7 years. Norplant is effective for only 5 years. Both types of IUD can disturb 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 diseases.

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.

PIP: Costa Rica has an estimated population of 3.2 million people. Contraceptive prevalence in the country was 75% in 1993, 99% of married or cohabiting women have heard about male condoms, and 96% know where to get them, but only 16% use them. Other barrier methods are either not widely used or are unavailable. Barrier contraceptive methods, however, are the only type of contraceptives which can be used to reduce the risk of contracting sexually transmitted diseases, including HIV. Even though female condoms are not yet widely available throughout Costa Rica, a study was conducted to assess short-term female condom acceptability among 51 female prostitutes in San Jose, Costa Rica. Each woman was trained how to use the female condom and asked to use it if clients refused to use male condoms during the 2-week study period. At the first of 2 scheduled follow-up visits, 51% of the women reported that they were thoroughly satisfied with the female condom, while 45% reported liking it somewhat. Similar results were reported after the second follow-up visit. 67% of the participants preferred the female condom over the male condom and the women reported that more than half of their clients liked the female condom either very much or somewhat. The most common problems encountered during the first phase of the study were difficulty in inserting the condom (61%) and discomfort (43%). However, the levels of these problems fell to 22% and 25%, respectively, during the second phase of study, while other use-related problems were noted. Study findings highlight the need to make female condoms more widely available in Costa Rica.

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.

PIP: The protective effect of consistent condom use against HIV transmission in HIV-serodiscordant couples has been documented. Unknown, however, is the anti-HIV effect of nonoxynol-9 use. This issue was addressed in a survey of 110 HIV-discordant couples from Lusaka, Zambia, who were willing to use condoms/spermicide, maintain a coital log, and return for follow-up visits every 3 months for at least 1 year. 80 of these couples (73%) had a seropositive man and 30 (27%) had a seropositive woman. The mean duration of follow-up was 17.6 months. Of the total of 15,148 recorded coital episodes, 10% were protected by condoms only, 17% by nonoxynol-9 only, 66% by both condoms and nonoxynol (according to the study protocol), and 6% were unprotected by any barrier method. Consistent barrier method use declined with duration of follow-up. There were 14 seroconversions (8.9 infections/100 couple-years), including 8 initially seronegative men and 6 initially seronegative women. Among couples who used condoms 0-50%, 51-75%, 76-99%, and 100% of the time, the seroconversion rates were 20.8, 10.1, 7.3, and 2.3/100 couple-years, respectively. Seroconversion rates were 6.9 and 8.9/100 couple-years among those reporting consistent and inconsistent use, respectively, of nonoxynol-9. Although this study failed to provide evidence that nonoxynol-9 use confers significant protection against HIV infection, its small size and the consistency of concurrent male condom use limited inferences.

Contraceptive use and HIV infection in Kenyan family planning clinic attenders.

This pilot study aimed to determine the feasibility of a larger study of contraception and risk of HIV infection in women. We also measured risk factors for and occurrence of HIV infection in the participants. A cohort of 1537 seronegative women attending a family planning clinic in Nairobi, Kenya was enrolled and followed for up to 12 months per woman. HIV testing was done quarterly. A nested case-control analysis was done with seroconverting women (cases) and 3 matched controls per case, who had detailed interviews and received physical examinations and STD tests. The prevalence of HIV at enrollment was 6.1%; seropositive women were excluded from further analysis. The 12-month life-table cumulative incidence of HIV was 2.1 per 100 women (95% confidence interval [CI] 1.1-3.2). In the nested case-control analysis (17 cases and 51 controls), the crude odds ratio of HIV infection comparing oral contraceptive (OC) users with other women was 3.5 (95%) CI 0.8-21.5), which persisted after control for single confounders at a time. The putative association between OC use sand HIV infection is critical to public health policy, yet no study has been conducted specifically to measure it, yielding weak and conflicting evidence. We intend to conduct a larger study with a similar design as the current pilot study, which confirmed the feasibility of a more definitive project.