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Research Briefs on Contraceptive Technology from Family Health International

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  • David Hock
    Contraceptive and Reproductive Health Technologies Research and Utilization (CRTU) Program January to March 2008 Research News * HIV-Prevention Studies of
    Message 1 of 1 , May 30, 2008
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      Contraceptive and Reproductive Health Technologies
      Research and Utilization (CRTU) Program

      January to March 2008

      Research News

      Research to Practice News

      Research News

      HIV-Prevention Studies of SAVVY Vaginal Gel Stopped Because of Futility

      Final results are now available for two USAID-supported clinical trials — one in Nigeria and one in Ghana — that were closed early because a low incidence of HIV among the participants prevented scientists from detecting an effect of the SAVVY candidate microbicide. For statistical reasons, a continuation of either study could not have established SAVVY’s ability to prevent HIV infections.

      Both studies began in 2004, when Family Health International (FHI) and its partners enrolled more than 4,000 HIV-negative women at high risk of HIV infection. Each participant in these Phase III trials was randomly assigned to receive either the SAVVY gel or a placebo gel.

      The participants were instructed to use the assigned gel and a male condom at every act of sexual intercourse. Participants returned to the clinic on a monthly basis for 12 months to be tested for HIV and pregnancy. The participants reported their use of the gel and condoms, as well as the occurrence of any side effects or medical problems.

      The new data show that no serious side effects were attributed to SAVVY use in the Nigerian study. Participants who used SAVVY in the Ghanaian study were slightly more likely to experience side effects in the reproductive tract than were users of the placebo. The Ghanaian study was closed in 2005, whereas the Nigerian study was closed in 2006.

      To read more about these studies, see:

      http://dx.doi.org/10.1371/journal.pone.0001474

      and http://dx.doi.org/10.1371/journal.pone.0001312.

       

      Sources

      Feldblum PJ, Adeiga A, Bakare R, Wevill S, et al. SAVVY vaginal gel (C31G) for prevention of HIV infection: A randomized controlled trial in Nigeria . PLoS ONE 2008;3(1):e1474.

      Peterson L, Nanda K, Opoku BK, Ampofo WK, et al. SAVVY® (C31G) gel for prevention of HIV infection in women: A phase 3, double-blind, randomized, placebo-controlled trial in Ghana . PLoS ONE 2007;2(12):e1312.

      Study Demonstrates Feasibility of Important Clinical Trial

      Results of a USAID-supported survey suggests that women in South Africa and Jamaica would be interested in participating in a clinical trial to examine the possible relationship between hormonal contraception and increased risks of acquiring sexually transmitted infections (STIs). Results also show a high rate of STIs at the survey sites — another sign that a clinical trial would be feasible.

      Clients from two family planning clinics and one STI clinic were given detailed information on a proposed trial in which women would be randomly assigned to use an intrauterine device or an injectable contraceptive. The clients then answered questions to determine how well they understood the study and how interested they would be in participating. They also provided urine or endocervical samples so that the scientists could determine their prevalence of STIs.

      Nearly all of the 190 women who completed the survey appeared to understand the proposed trial well, and more than two-thirds expressed interest in participating. About 28 percent of the women tested positive for chlamydial infection, and 9 percent tested positive for gonorrhea.

      Some observational studies have suggested that the use of hormonal contraception increases a woman’s risk of acquiring STIs. Data from the largest prospective study ever conducted on this topic showed no association between the use of hormonal methods and acquisition of HIV. However, the study did not examine the relationship between use of the methods and acquisition of other STIs. A randomized controlled trial would help determine whether such a relationship exists and, if so, the nature of that relationship.

      To read more about this topic, see:

      http://dx.doi.org/10.1016/j.contraception.2008.01.006.

       

      Source

      Hubacher D, Raymond ER, Beksinska M, et al. Hormonal contraception and the risks of STI acquisition: results of a feasibility study to plan a future randomized trial. Contraception 2008;77(5):366-370. Epub 2008 Mar 18.

      Statistical Modeling Provides Reassurance to West African Women Who Use the Intrauterine Device

      The risk of pelvic inflammatory disease (PID) that can be attributed to the use of an intrauterine device (IUD) is very low in West Africa , according to statistical modeling performed with support from USAID.

      Scientists used data from a 2004 study conducted in Benin , Burkina Faso , Ghana , Guinea , and Mali to calculate the risk of PID that could be attributed to IUD use. They found this risk to be only 0.075 percent — less than 1 in 1,300.

      The myth that women who use an IUD are at high risk of developing PID is partly responsible for the decreased use of IUDs in many parts of the world. The new findings underscore the importance of education, training, and policy changes in overcoming this mistaken perception. This could help increase acceptance of the IUD, which has been proven to be a low-cost, safe, and highly effective form of reversible contraception.

      To read more about this topic, see:

      http://dx.doi.org/10.1016/j.contraception.2008.01.001.

       

      Source

      Stanback J, Shelton JD. Pelvic inflammatory disease attributable to the IUD: modeling risk in West Africa . Contraception 2008;77(4):227-229. Epub 2008 Mar 4.

      Updated Cochrane Review Compares Three Hormonal Methods of Contraception

      An updated Cochrane review, conducted with partial support from USAID, highlights similarities and differences between combined oral contraceptives and some newer contraceptive alternatives.

      The authors specifically reviewed randomized controlled trials comparing combined oral contraceptives with either the skin patch or the vaginal ring. They identified three trials involving the skin patch and eight involving the vaginal ring. Analyses compared data on contraceptive effectiveness, cycle control, compliance, and safety.

      Contraceptive effectiveness was similar for all three forms of contraception. Although women reported more consistent use of the patch than of pills, patch users were more likely than either pill or ring users to discontinue the trials early. This may have been due to side effects.

      Compared to pill users, 1) patch users noted an increased incidence of breast discomfort, painful periods, nausea, and vomiting; 2) ring users noted less nausea, irritability, and depression; and 3) ring users had fewer bleeding problems but more vaginal irritation and discharge.

      All three of the hormonal methods studied here are considered safe and effective. According to a separate review of the literature, the first-year failure rate for each method is only 0.3 percent if a woman uses it perfectly. During more “typical” use, for example when a woman forgets to take her pills or change her patch, the first-year failure rate for each method is about 8 percent.

      To read more about this topic, see:

      http://dx.doi.org/10.1002/14651858.CD003552.pub2.

       

      Source

      Lopez LM, Grimes DA, Gallo MF, Schulz KF. Skin patch and vaginal ring versus combined oral contraceptives for contraception. Cochrane Database Syst Rev 2008;23(1):CD003552.

      Training Program Aimed at On-Site Supervisors Can Improve Quality of Care

      An intervention to train on-site, in-charge reproductive health supervisors significantly improved the quality of care at the levels of supervisors, providers, and client-provider interactions.

      The USAID-sponsored study evaluated JHPIEGO’s “supportive supervision” training package — called Performance Quality Improvement — at 60 health facilities in Kenya . At the end of the intervention, data were collected to evaluate the supervisors' techniques and knowledge. When compared with supervisors who were not trained, those who were trained were more knowledgeable of techniques for assessing provider performance, motivating staff, and communicating expectations to staff. Supervisors in the training group were also more likely to observe provider-client interactions and to give feedback to the providers regarding these interactions. Providers in the training group improved in their communication with clients, infection-prevention practices, and attention to standards of confidentiality. All of these changes were statistically significant.

      Changes in client satisfaction, while promising, did not prove statistically significant. Additional studies with larger sample sizes and different measures of the clients' experience may help to evaluate this dimension further.

      The techniques used to train supervisors in this study were not specific to the provision of reproductive health services. Therefore, this kind of intervention could also be useful to other types and levels of health care supervisors. The training program cost US $2,113 per supervisor trained, but could be less costly if implemented locally.

      To read more about this topic, see:

      http://dx.doi.org/10.1093/heapol/czm037.

       

      Source

      Reynolds HW, Toroitich-Ruto C, Nasution M, Beaston-Blaakman A, Janowitz B. Effectiveness of training supervisors to improve reproductive health quality of care: a cluster-randomized trial in Kenya. Health Policy Plan 2008;23(1):56-66.

      Imaging Techniques May Help Characterize Vaginal Microbicides

      A USAID-supported study shows that three different imaging techniques provide valuable information about the movement of a vaginal gel inside a woman’s vagina. This information may be particularly useful in the development of a vaginal microbicide to prevent HIV.

      Magnetic resonance imaging, gamma scintigraphy, and a fiberoptic probe were used to evaluate the movement and retention of gels inside the vagina. The scientists used two microbicide surrogates — Replens gel and K-Y Jelly.

      The scientists showed how a woman’s body movements, the number of children she has had, and her body mass index can affect the diffusion and retention of a vaginal gel. They also identified unique advantages and disadvantages of the imaging techniques and concluded that the three techniques would provide complementary information about a microbicide.

      Although microbicides can be produced in many forms, most of the current candidates are formulated as gels. The ideal microbicidal gel would spread quickly, completely covering both the vaginal walls and the outer part of the cervix. It would also stay in place throughout sexual intercourse. More than 30 microbicide candidates are in some stage of laboratory or clinical development. No product has yet been shown to prevent HIV in humans.

      To read more about this topic, see:

      http://dx.doi.org/10.1016/j.contraception.2007.11.016.

       

      Source

      Mauck CM, Katz D, Sandefer EP, Nasution MD, et al. Vaginal distribution of Replens and K-Y Jelly using three imaging techniques. Contraception 2008 77(3):195-204.

      Research to Practice News

      Family Health International Facilitates Family Planning Workshop in Mali

      With support from USAID, Family Health International (FHI) was a guest facilitator at the “Basics of Community-Based Family Planning Workshop” held in Bamako , Mali , on February 4-15, 2008.

      The workshop, organized by ORC Marco under its Child Survival Technical Support project, gave about 30 Flexible Fund grantees and partners an opportunity to share their programmatic experiences in community-based family planning. The participants came from eight countries: Mali , Senegal , Niger , Burkina Faso , Madagascar , Guinea ,

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