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Evidence-Based Planning of a Randomized Controlled Trial on Diaphragm Use for Prevention of Sexually Transmitted Infections

Behets, Frieda M. T. F. PhD*†; Van Damme, Kathleen MD†‡; Turner, Abigail Norris PhD*; Rabenja, Ny Lovaniaina MD‡; Ravelomanana, Noro L. R. MD‡; Raharinivo, Mbolatiana S. M. MD‡; Zeller, Kimberly A. MD§; Rennie, Stuart M. PhD∥¶; Swezey, Teri A. PhD*

Sexually Transmitted Diseases: March 2008 - Volume 35 - Issue 3 - pp 238-242
doi: 10.1097/OLQ.0b013e31815abaa2

Objectives: We conducted formative research to evaluate the acceptability and feasibility of continuous diaphragm use among low-income women highly exposed to sexually transmitted infections (STIs) in Madagascar.

Goal: To identify potential obstacles to researching the effectiveness of diaphragm use for STI prevention in a randomized controlled trial.

Study Design: Mixed methods to collect complex information. In a quantitative pilot study, women were asked to use diaphragms continuously (removing once daily for cleaning) for 8 weeks and promote consistent male condom use; they were interviewed and examined clinically during follow-up. Focus group discussions (FGDs) were conducted pre-/postpilot study. Audiotaped FGDs were transcribed, translated, coded, and analyzed.

Results: Ninety-three women participated in prepilot FGDs, 91 in the pilot study, and 82 in postpilot FGDs. Diaphragm use was acceptable and feasible, but participants reported lower condom use in FGDs than during interviews. Most participants reported in interviews that they used their diaphragms continuously, but FGDs revealed that extensive intravaginal hygiene practices may impede effective continuous diaphragm use. Despite counseling by study staff, FGDs revealed that participants believed the diaphragm provided effective protection against STIs and pregnancy.

Conclusions: Mixed methods formative research generated information that the prospective pilot study alone could not provide and revealed contradictory findings. Results have methodological and ethical implications that affect trial design including provision of free hormonal contraceptives, and additional instructions for vaginal hygiene to avoid displacing the diaphragm. Mixed methods formative research should be encouraged to promote evidence-based study design and implementation.

Mixed-methods acceptability/feasibility research before an RCT provided crucial understanding of continuous diaphragm use including inconsistent reporting by sex workers in Madagascar compared to pilot study alone.

From the Departments of *Epidemiology, and †Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; ‡UNC-MAD, Antananarivo, Madagascar; §Department of Family Medicine, Brown University, Providence, Rhode Island; and Departments of ∥Social Medicine and ¶Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

The authors thank Myron Cohen, Barbara Savarese, Carolyn Deal, Wendy Githens Benazerga, and Jocelyne Andriamiadana for their support.

The content of this report does not necessarily reflect the views or opinions of the funding agencies.

Supported by Sexually Transmitted Diseases Clinical Trials Unit, NO1-75329; United States Agency for International Development, Antananarivo, Madagascar.

Correspondence: Frieda Behets, PhD, MPH, Department of Epidemiology, School of Public Health, CB 7435, Chapel Hill, NC 27514. E-mail:

Received for publication April 2, 2007, and accepted September 9, 2007.

DEVELOPMENT OF NEW METHODS TO PREVENT acquisition of sexually transmitted infections (STIs) and HIV is a crucial research priority, particularly among women.1–4 The diaphragm, originally designed as a contraceptive product, may also have STI/HIV-prevention qualities; it covers the cervix (the preferred infection site for gonorrhea, chlamydia, and HIV) and can be used by women without involvement of their male partners.5,6 Since the cervix is a portal to the upper genital tract, some morbidities of bacterial STIs may also be averted.7–12

Several observational studies found diaphragm users at lower risk for STIs and long-term sequellae.7–16 However, randomized controlled trials (RCTs) are needed to determine the effectiveness of the diaphragm for prevention of STI acquisition.17

High STI rates have been documented among women of mainly low-socioeconomic status in Madagascar who practice sex work. In 2001, 75% to 78% of asymptomatic female sex workers (SWs) had at least 1 curable STI, and up to 30% had gonococcal and/or chlamydial infections. Cervical infection remained common even after presumptive treatment and condom promotion.18,19

We conducted a formative study in preparation for a RCT that will determine the effectiveness of the diaphragm used continuously without microbicide, spermicide, or lubricant in reducing acquisition of Chlamydia trachomatis and Neisseria gonorrhoeae. Before this research, diaphragms were virtually unknown and unavailable in Madagascar. The objectives were to identify potential obstacles to researching the effectiveness of diaphragm use for STI prevention in a RCT. We used mixed methods, i.e., qualitative focus group discussions (FGDs), as well as a quantitative prospective pilot study in this formative research.20 The results of the quantitative research have been reported elsewhere21; here, we present results from the qualitative research and compare these with findings from the published quantitative pilot study.

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Materials and Methods

Justification for Mixed-Methods Formative Research

We identified several challenges during the planning of the RCT. Introducing a potential STI prevention method in the spirit of harm reduction22 among impoverished women living in a context of pervasive scarcity and vulnerability while having to trade sex for survival is complex. For ethical reasons, we will promote consistent male condom during the RCT; we will also ask participants to use the study product continuously. We expect that most participants will wear the diaphragm continuously when they anticipate sexual intercourse might occur, but that most participants will not be able to convince their male partners to use a condom consistently. However, differential condom use in the 2 study arms could bias our intent-to-treat analyses, and understanding patterns of and changes in condom use was a priority of our formative work. In addition, treatment allocation cannot be concealed and participants and staff will know to which randomization arm each participant belongs. Use of a diaphragm could change participants’ willingness to insist on condom use with their partners and could also influence staff counseling messages towards participants.

We deemed a quantitative, prospective pilot study to assess acceptability and feasibility of a planned RCT23 as necessary but not sufficient. Participants might report desirable rather than true behaviors and using mixed methods might be complementary24 and improve validity.

We chose FGDs as our qualitative research method because they can facilitate open discussions of sensitive topics, including sexual behavior, by participants who might be more reserved about discussing their views and experiences in individual interviews.25–27 FGDs can also offer a culturally appropriate means of data collection in settings where people are accustomed to discussing sensitive topics in same-sex groups.28 Group interaction and debate during FGDs can reveal social norms and practices that might affect the outcomes of interest and allow researchers to understand participants’ attitudes and experiences in their own terms.25,26,29

FGDs have been used in Madagascar with population groups at high risk for HIV/STI, including SWs, to evaluate prevention messages and risk behavior.30 FGDs, alone or in combination with other qualitative or quantitative methods, are frequently utilized in HIV/STI and contraception research to assess the acceptability of woman-initiated prevention methods.4,31–43

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Research Design and Methods

The formative research was carried out in Madagascar in 2004 at 3 public health clinics that provide routine STI care and prevention for SWs: Isotry in Antananarivo, Hopitaly Kely in Toamasina, and Hopitaly Mahabibo in Majunga.

Women were eligible if they were self-identified SWs who reported less than 100% condom use with clients in the past month, were not pregnant or did not desire to get pregnant in the next 6 months, and were able to be fitted with a diaphragm.

At the start of the pilot study, SWs were taught how to insert and remove the diaphragm. The women were asked to use their diaphragm continuously for 8 weeks, and remove it once daily for washing at least 6 hours after the last sex act.

As part of the informed consent process, women were informed of the existing contraceptive use of the diaphragm while explaining that the diaphragm does not provide adequate pregnancy prevention without spermicide. Women were also told that the diaphragm has not been proven to protect against STIs. In addition, participants were encouraged to use male condoms with all partners for all sex acts.

At enrollment and each follow-up visit for the pilot study, participants were interviewed about their sexual and reproductive behavior, including use of condoms and diaphragms, contraceptive use, and vaginal hygiene practices. Women were interviewed and examined clinically at baseline and after 1, 4, and 8 weeks of follow-up. At the enrollment visit, syphilis testing was performed using RPR (Rapid Plasma Reagin, Becton Dickinson, Cockeysville, MD) and women were treated following the national guidelines.18

Twelve FGDs were conducted before the pilot study and 12 after the women completed participation in the pilot study. The FGDs were designed to capture knowledge and attitudes towards diaphragm use, perceived STI and pregnancy risk, and potential obstacles for conduct of the trial. FGDs were conducted in Malagasy and facilitated by 2 trained female researchers who used a semistructured guide. Participants were told that they could use a name other than their own to maintain anonymity. Taped FGDs were transcribed from Malagasy verbatim, translated into French and English and verified for accuracy.

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Qualitative Data Analysis

The qualitative data were iteratively coded for a priori themes based on research questions as well as data-driven themes that emerged during analysis.44,45 Multiple analysts independently coded and analyzed the data in 2004 to improve the reliability and validity of the findings.46,47 Transcripts were coded in French by one of the Malagasy facilitators and another French-speaking Malagasy staff member; both are clinicians. Their coding and analyses were translated into English to facilitate later comparisons with the analysis of the third coder (English-speaking). Upon completion of their independent analyses, the 3 coders met and discussed their respective findings, reaching consensus about the major themes in the data.

Subsequent rounds of coding of the English transcripts were done independently in 2005 by a U.S.-based team member who had not participated in the field research. Data were organized into display tables to facilitate the comparison of themes and subthemes within and across FGDs. Analysts in Madagascar and the United States reached consensus about the most representative findings from all phases of coding, which are presented here.

The research was approved by the Institutional Review Boards of the Ministry of Health and Family Planning, Antananarivo, Madagascar, and of the University of North Carolina at Chapel Hill.

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Using community-based outreach, peer counselors invited SWs to present at each of the clinics for their 3 monthly routine visits. Women were recruited as they presented consecutively at the clinics. All women (n = 97) approached by study staff agreed to be screened; 91 eligible women were enrolled in the prospective pilot study and 96% (n = 87) completed 8 weeks of follow-up. Ninety-three women participated in prepilot FGDs; 82 women participated in postpilot FGDs. FGDs were age stratified (under age 24 and age 25 and above) to facilitate open discussion. On average, 7–8 women participated in each FGD.

The median participant age was 28 years (range, 18–48); 84% were unmarried or were not living with a partner. The median number of pregnancies reported by the women was 2 (range 0–7). The median years of school completed was 5 (range 0–13).

At the start of the pilot study, women reported a median of 6 sex acts (range: 0–40) with 5 sex partners (range: 0–40) in the previous week. A history of genital ulcers was reported by 37% of the women; 27% were RPR reactive.

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Reported Condom and Diaphragm Use

Prepilot FGDs showed that women were aware of the need to protect themselves from STIs but often encountered resistance to condom use from male partners. The majority of women reported having unprotected sex when short of money (a common scenario). Many clients refuse to use condoms and several women felt unable to negotiate condom use, recognizing that many of their clients are paying for the ability to have sex without condoms. Women also reported that some men pay more for unprotected sex: “Since the time we knew of AIDS, that’s what we were mostly afraid of. Our clients are dead set against using condom (pre-FGD4) … He says, ‘I’m spending my own money, I won’t use a condom’.” (pre-FGD11)

As found previously18,19,48–52 women reported using condoms less frequently with their boyfriends or husbands. Most women’s comments suggest that they do not use condoms with regular partners because of the trust and love implied in a nonclient relationship: “Clients are different because they come and go whereas you have sex with your sipa [boyfriend] regularly and you love him; it is not the same” (pre-FGD1). Several women mentioned that condom use with regular partners might imply mistrust and decrease sexual pleasure.

Women were asked during the prepilot FGDs whether they thought using the diaphragm might decrease condom use. Some comments during these prepilot FGDs suggested that women might feel less concerned about having unprotected sex because of the perceived protection provided by the diaphragm: “Now that we’ve got this to protect us, we no longer care if they use condoms or not” (pre-FGD3). One woman’s strongly worded response to the recommended protocol of using condoms along with the diaphragm during the prospective pilot study revealed the realities of women’s lives and the potential for decreased condom use among some women:

“Everyone here is looking for money, and we are all fully aware of the fact that the majority of us don’t use condoms unless the clients themselves ask for it. So, with the diaphragm, we’ll no longer care to use condoms unless the client asks us to, I mean those clients who are used to it. So don’t tell us that we’ll keep on using condoms all the time even if we are wearing the diaphragm! We will make our own choices. We don’t act the same. You don’t know if I’ll still be using condoms with the diaphragm. Maybe I won’t care anymore.” (pre- FGD1).

During the pilot study, women reported in structured interviews of male condom use during 61% of sex acts at enrollment and 65%, 70%, and 67% at the subsequent follow-up visits. At the first follow-up visit, women reported using diaphragms during 97% of their sex acts, and reported diaphragm use remained high: 97% of sex acts covered at the 4-week visit and 95% at the 8-week visit.21

However, some women’s comments during postpilot FGDs suggested decreased condom use. Despite being informed repeatedly by study staff about the unknown benefits of the diaphragm for STI and pregnancy prevention, most women believed that the diaphragm provided effective protection against STIs and pregnancy. Decreases in condom use reported during FGDs by some women may have been linked to this belief.

Women who reported reduced condom use in FGDs may have been less concerned about their partners’ refusal to use condoms because of their belief in the protective benefits of the diaphragm:

* “… it is very useful because it protects from diseases and unwanted pregnancies.” (post-FGD6)

* “So, I like using this thing [the diaphragm] because what I should catch, I don’t catch because I use it. When I had a checkup I noticed that this thing really protects me.” (post-FGD7)

* “I already had this device, so why bother getting condoms?” (post-FGD2)

* “I used to use condoms with my regular partner … and since I have the diaphragm, I haven’t used a condom yet with [him].” (post-FGD6)

* “I was no longer afraid of catching infection or getting pregnant whether I used a male condom or not. I was ready all the time because I got this device in place. I didn’t need to worry when I used it … I’ve got a diaphragm condom inside me.” (post-FGD2)

The reported high diaphragm use throughout the follow-up period was supported by women’s enthusiastic comments during postpilot FGDs about the diaphragm as effective protection against STIs and pregnancy.

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Vaginal Hygiene Practices

Discussions of vaginal hygiene in pre- and postpilot study focus groups suggest that women’s intravaginal hygiene practices (referred to as “digging” or “scouring”) may influence effectiveness of continuous diaphragm use. In prepilot FGDs the majority of women reported routine intravaginal hygiene practices, using their forefinger and water, generally 2–3 times a day when they bathe or shower as well as between clients. Women reported cleaning themselves internally between clients to remove “the man’s dirt” and because clients “don’t like the fact that you have had sex with another person and neither do you … you have to wash before you go to the next client.” (post-FGD1)

During the prepilot FGDs, the majority of women predicted that they would be able to follow the continuous-use protocol. Postpilot FGDs suggest that the majority of women followed the “6-hour rule” and waited as instructed to remove, wash, and reinsert the diaphragm. However, some women washed their diaphragms 2–3 times a day. Several of the women who reported sex without a condom removed the diaphragm and cleaned it as part of their intravaginal hygiene between clients:

* “Because you see one client after another. You feel dirty and uncomfortable, so you must wash. And you take it out when you are cleaning yourself.” (post-FGD1)

* “This way, the client will think that he is the first man you’re having sex with … [otherwise] he will just think that you’ve had sex with another client and you didn’t clean yourself. [He will think] the girl is definitely not clean, her vagina is so slippery.” (post-FGD1)

* “I don’t feel at ease because it is sticky … so I took it off and washed it. I don’t do that everyday. It’s only when I have clients who pay a lot of money [for sex without a condom] … your fingers touch it and it is sticky. You have to get rid of it because it is disgusting.” (post-FGD3)

Overall, women were fairly comfortable speaking and debating openly in the prepilot FGDs. However, the facilitators tended to correct women’s misconceptions, which decreased spontaneity. These corrections focused on women’s misunderstandings about the protective effect of the diaphragm for pregnancy and/or STI prevention. Women’s responses following facilitators’ corrections in the prepilot FGDs are not reported here.

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Both quantitative and qualitative methods indicated high acceptability of continuous use of the diaphragm among women of low socioeconomic status and education who are highly exposed to STIs. Women reported high product use during the prospective pilot study and were for the most part enthusiastic about the diaphragm in postpilot FGDs. We did not assess acceptability by male partners because women can use a diaphragm covertly. While acceptability is a complex combination of factors at the individual, couple, and societal levels,53,54 we focused on initial acceptability by intended users to assess the feasibility of a RCT.

The acceptability by the intended users was excellent. However, the use of mixed methods allowed us to capture contradictions in responses given by the participants depending on the research method used. Group interaction and discussion in FGDs generated context-rich data that provided insights into practices and social norms that are likely to impact the acceptability of the diaphragm for STI prevention and adherence to the recommended protocol of condom use with all partners.

Reported condom use increased during the course of the pilot study; reports of lower condom use in the postpilot FGDs may have been the result of decreased social desirability bias compared to individual interviewing. This demonstrates the need to minimize barrier substitution through appropriate counseling of all women so they ask their male partners to use condoms regardless of diaphragm use.

Qualitative research allowed us to explore issues that are hard to measure using quantitative methods,55 including vaginal hygiene practices. To address the intravaginal hygiene practices that might interfere with the trial objectives, a workgroup including in-country clinical researchers, SWs, and their peer counselors discussed the implications of vaginal hygiene practices for continuous diaphragm use. The workgroup focused on the participatory development of specific and “person in context”48 instructions for vaginal hygiene practices. These instructions emphasize adaptation and change and encourage women to avoid displacing or removing the diaphragm and exposing the cervix to semen and STIs.

The findings from our mixed-methods study have ethical as well as methodological implications; they affect the design of the RCT. The informed consent of the RCT does not need to mention the contraceptive qualities of the diaphragm. Many participants thought the diaphragm was effective against pregnancy even when used without a spermicide, contrary to the provided information. Telling potential trial participants about the contraceptive properties of the diaphragm would knowingly fuel risk of harm by increasing the exposure of trial participants to unintended pregnancy. While one might argue against this restriction of autonomy in the short term, avoidance of unintended pregnancies is likely to promote autonomy in the long term. In this particular case, it can be argued that less information during the informed consent process better protects the welfare of the trial participants.

More generally, the amount of information potential research participants need to absorb and digest during the informed consent process needs to be balanced against the quality of their understanding of all the research components that are relevant to them. Potential research participants should not be forced to receive nonessential information, as they are systematically encouraged to ask questions during the informed consent process. Offering hormonal contraceptives free of charge may further avoid potential misunderstandings and unintended pregnancies.

Combining qualitative and quantitative research generated a richer, more comprehensive understanding of diaphragm use acceptability and feasibility among study participants. Mixed-methods formative research filled crucial gaps in knowledge that a prospective pilot study alone could not have provided. The qualitative research also allowed us to detect contradictions in responses. Incorporating qualitative research into RCT design and conduct has been recommended previously.56,57 Changes to the content and delivery of study information based on qualitative research results improved acceptability and recruitment rates from 40% to 70% in 1 study.58

Mixed methods such as instrument building, triangulation, and data-transformation models have been recommended for improved primary care research.59 However, qualitative research is mostly ignored by major clinical journals60 and by many biomedical research funding agencies. Our research provides a concrete example of the usefulness and actionability of mixed methods formative research.61

“Qualitative research findings close the gap not only between understanding and action but also between efficacy (or what works in research) and effectiveness (or what works in practice).”61 Qualitative and mixed methods research should be encouraged by agencies that fund RCTs to avoid mistakes that are costly for trial participants, researchers, and society. Major biomedical journals should publish qualitative and mixed methods research to promote evidence-based study design and implementation.

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