2.1. Study setting
This study is conducted in Mbarara district, South Western Uganda. Contraceptive use has significantly increased in Uganda. Its use among married women increased from 14% in 2001 to 35% in 2014 . Like other countries in SSA, HECs are getting the norm in Uganda, with 32% of currently married women using them in 2014 . Injectable is the most used method (19%) followed by implants (6%), female sterilization (3%), pills (2%) and IUD (2%) . Despite the significant increase in contraceptive use, an estimated 46% of pregnancies were unintended in Uganda in 2018 . The HIV prevalence among adults 15–64 years is 6.2% and is higher among women (7.6%) than among men (4.7%) . The South-West region had the second highest HIV prevalence (7.9%) after the Central region (8.0%) in Uganda .
Mbarara district has one regional hospital, six general hospitals, four county-level health centers (health center IV), 14 sub-county-level health centers (health center III), 37 parish-level health centers (health center II) . Among them, 48 are public health facilities, and 23 facilities are located in urban areas . Family planning service is provided for free at all the levels of health centers. Male and female condoms are also provided free by the Ministry of Health and by local and international non-governmental organizations . Condoms can also be purchased from supermarkets and pharmacies for United States Dollar (USD) 0.15 to USD 0.50 .
2.2. Study objectives
The objectives of this study are to (i) identify unique behaviors that are common only among married women who practice dual-method use with their partners in an HIV-prevalent setting in Uganda and (ii) evaluate the effect of an intervention formulated under the positive deviance approach for promoting dual-method use among married women using HECs.
2.3. Study design
This study consists of Phase I and II. In Phase I, eligible women will be screened with a structured questionnaire. Then, in-depth interviews will be conducted with all women practicing dual-method use and ten women using only HECs to identify unique practice that is common only among women practicing dual-method use (positive deviants). In Phase II, a cluster randomized controlled trial (C-RCT) will be conducted to assess an intervention formulated under the positive deviance approach for promoting dual-method use. The intervention will consist of clinic-based and phone counselling and a participatory workshop which will be tailored based on the unique practice identified in Phase I. The overall study flow chart is shown in figure 1. The schedule of the C-RCT is shown in the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) figure (figure 2). The SPIRIT checklist is provided in additional file 1.
2.3.1. Phase I: identify positive deviants
Sample size, eligibility, and recruitment
In Phase I, 150 women will be interviewed. This is based on the assumption that at least 7% of women would practice dual-method use , and at least ten women who are considered as a positive deviant would be identified.
To be eligible for joining in this study, participants should have the following characteristics: (i) women, (ii) 18-49 years old, (iii) sexually active, (iv) using HECs at the time of recruitment (v) have a desire to avoid pregnancy for 12 months from recruitment (vi) have a husband or live-in sexual partner, and (vii) have access to a valid phone number.
Being sexually active is defined to have had sexual intercourse in the last three months before the study . Pregnant women and women who are infertile for other reasons will be excluded from this study. Health workers, including community health workers, political and religious leaders, and teachers will also be excluded because they may not represent communities or be influenced by their occupations and social status.
For sampling, five health facilities will be selected purposively. Then, five trained female research assistants will approach female clients in the family planning sections of the selected health facilities. The first client will be selected randomly at each clinic, and then every third client will be informed about the opportunity to participate in this study. If they are interested in participating, the research assistants will ask screening questions using a pretested questionnaire to check their eligibility for the study. This process will be repeated until the required sample size is met.
The five female trained research assistants will conduct face-to-face interviews using a pretested structured questionnaire with the participants. These interviews aim to identify women practicing dual-method use and their basic socio-demographic characteristics. Data collection items include basic socio-demographic characteristics, the types of HECs, the frequency of condom use in the past two months, and the histories of unintended pregnancies and diagnosed HIV/STIs. Women using both HECs and condom always will be regarded as practicing dual-method use. Dual-method users without no reported histories of unintended pregnancies and HIV/STIs will be considered as positive deviants.
Next, in-depth interviews will be conducted by the research assistants with all positive deviants to identify their unique practice, such as effective communication for condom use that is actually working. Then, ten women who do not practice dual-method use will be randomly selected for in-depth interviews to document common practices and verify if the practice identified in positive deviants is unique. The interviews will be open-ended, and an interview guide will be used. The interview guide focuses on the following domains: (1) perceptions of condom use and contraception, (2) reasons and motivations for condom use or nonuse, (3) negotiation and communication for condom use, and (4) risk perceptions for or unintended pregnancy and HIV/STIs.
The data collection tools were first developed in English and then translated to Runyankore by an independent researcher. They were back-translated to English by the Ugandan researcher (SM) to ensure the accuracy of the translation. All interviews will be conducted in either English or Runyankore. In-depth interviews will be audio recorded based on the consent of participants. All participants will be given some commodities worth of 10,000 Ugandan Shillings (UGX) (equivalent to 3 USD) after the initial interview, and those who participate in the in-depth interview will receive10,000 UGX for their time and transportation.
Data analysis plan
All qualitative interview data will be transcribed and if not in English, translated from Runyankore into English by a research assistant. Translated transcriptions will be compared with recorded data by the researcher (SM) to ensure their accuracy. Then, the two researchers (HK, SM) and the five research assistants who conducted in-depth interviews will read all the transcripts and code overarching themes using MAXQDA version 18. Then, data will be compared between dual-method users and nonusers to identify problems and barriers to adapting dual-method use and how they were overcome by positive deviants with their unique practice.
2.3.2. Phase II: Cluster randomized controlled trial
Sample, eligibility, and recruitment
The minimum required sample size for this trial is 588. It was calculated based on data from research on the effect of case management and peer education program on the uptake of dual- method use in the USA (Odds ratio: 1.58 with a 95% CI of 1.03 to 2.43) . The less conservative effect size of 2.43 was used because this trial will include only women who have already used HECs, unlike the prior research which recruited adolescent girls regardless of their contraceptive use . Then, an intraclass correlation coefficient (ICC) of 0.006 was considered [33, 34]. The ICC was adapted from a clinic-based condom use intervention in SSA . The required minimum sample size was 760 after considering the ICC. Considering 26% dropout rate, 960 participants will be recruited (480 participants in each arm) . The power of the study was set at 80%, and the significance level was set at 5%. Open Epi version 3 was used for the calculation.
Twenty health facilities will be purposively selected considering the size and rural/urban status. The same inclusion criteria as Phase I will be used for this intervention study, but when women are practicing dual-method use in the last two months prior to the recruitment, they will be excluded. The same sampling method as Phase I will be used to recruit women at health facilities. Eighty women will be recruited from each of hospitals and county-level health centers, 40 from each of sub-county-level health centers and parish-level health centers.
To minimize contamination across individuals, the C-RCT approach will be adopted . The 20 health facilities will be stratified based on the level of health facilities and urban/rural status and randomized to the intervention (n = 10 facilities) or control arm (n = 10 facilities) (1:1 allocation ratio), using a computer random number generator by the principal investigator (HK). The participants will be given the intervention that the facilities they were recruited at were allocated to.
The intervention will consist of a series of counselling and participatory workshop, planned based on the unique practice identified in Phase I. On the day of enrollment, women in the intervention arm will receive dual-method counselling with a tool developed based on the practice identified in Phase I, in addition to regular family planning counselling with an existing counselling tool . The dual-method counselling will be conducted for 20-40 minutes by trained research assistants.
Two weeks after the enrollment, women in the intervention arm will be invited for a one-day participatory learning workshop (five hours) at the same health facilities where they are recruited. Women may decide whether to participate or not. The workshop will be facilitated by research assistants and positive deviants, using a training protocol developed after Phase I. It will include simulations and role-plays for successful communication to use a condom with their partners and a group discussion regarding family planning and HIV/STI risk.
Bimonthly telephone counselling will be provided by positive deviants three times (three, five, and seven months after the enrollment). Each counselling will take 10-20 minutes and aim to remind women of the risk of unintended pregnancies and HIV/STIs and strengthen their capacity to communicate to use a condom with their partners. The two-month intervals can allow women to reflect on counselling messages, discuss condom use with their partners, and put it into practice. Positive deviants, therefore, can provide more effective counselling tailored to participants’ individual needs through understanding their situation.
Women in the control group will be provided regular family planning counselling including dual-method use for 10-30 minutes by trained research assistants using the same existing tool on the day of enrollment . Moreover, refresher training will be provided bimonthly on family planning and HIV/STI risk via phone, by research assistants three times (three, five, and seven months after the enrollment).
Condoms will be provided for free, regardless of the allocation at the selected health facilities. Before the intervention starts, the research assistants will receive two-day training about the contents of the existing counselling tool by health professionals .
The primary outcome is dual-method use. In this study, dual-method use is defined as the use of male or female condom along with HECs such as pills, injectable, implants, male and female sterilization, and IUD consistently in the last two months, prior to each follow-up interview . The outcome measure combines two questions regarding the frequency of condom use and HEC use. The frequency of condom use will be asked with an item: “How often did you and your partner use a male or female condom during the past two months?” Women will answer this question using a four-point scale “every time,” “almost every time,” “sometimes,” and “never.” Only those who answered “every time” will be considered as having consistent condom use. Women will also be asked if they have been using any HECs with a question, “Apart from condoms, have you been using any other forms of protection against pregnancy during the past two months?” Responses to these two questions will be used to construct the dual-method use outcome with the following categories: the following categories: (i) dual-method use (consistent condom and HEC use), (ii) inconsistent condom and HEC use, and (iii) single or no contraceptive method use.
The secondary outcome is the self-reported first occurrence of pregnancy and STIs in the previous two months . They will be assessed with the following two questions: “Have you been told by a health care provider that you got pregnant for the first time in the past two months?” and “Have you been told by a health care provider that you had any STIs such as chlamydia, gonorrhea, or trichomonas infection for the first time in the past two months?”
The following information will be collected during the baseline interviews to conduct sub-group analyses and to identify factors associated with condom use: age, education, employment, area of residence (rural or urban), reproductive history, pregnancy intention, sexual history, STI history, substance use, domestic violence, contraceptive methods in use, awareness of dual-method use, spousal communication on family planning, HIV status of participants and their partners, disclosure of HIV status, antiretroviral therapy (ART) treatment status [14, 22, 38], HIV-related knowledge (HIV-KQ-18) , perceived STI and HIV infection risk , condom use self-efficacy , sexual relationship control power (the Sexual Relationship Power Scale: SRPS) , and women's perception of the social acceptability of contraception .
On the day of enrollment, all women will be interviewed using a pre-tested structured questionnaire to identify basic baseline characteristics. Then, they will be followed up via phone bimonthly for eight months to assess how the intervention influences on dual-method use and pregnancy and STI incidence (two, four, six, and eight months after the enrollment). All interviews will be conducted by trained female research assistants using an interview guide in either English or Runyankore. All data will be entered using EpiData version 4.6.
All participants will be given some incentives worth of 10,000 UGX (equivalent to 3 USD) for their time and participation in the study after the initial interviews. Participants who participate in the learning workshop will receive 20,000 UGX (equivalent to 6 USD) for transportation.
The background characteristics of women will be compared between the intervention and the control group using Pearson’s chi-squared or Fisher’s exact tests . Mixed effects logistic regression analysis will be performed with a random effects term for the clusters to access the effect of the intervention on the following outcomes: dual-method selection and adherence, self-reporting pregnancy and STI incidence in the two months before each follow-up data collection. In addition, hierarchical logistic regression model will be introduced to ascertain the predictors of each outcome. Model 1 will be adjusted for demographic variables, such as age, education, and the number of children. Model 2 will be adjusted for the status of residence (urban or rural) in addition to demographic variables. Model 3 will include the type of HECs at the baseline sequentially, which is known to be associated with dual-method use [8, 45]. Model 4 will be adjusted for variables related to their partners, such as partner’s attitude toward family planning. Model 5 will include women’s perceived risk of HIV/STIs. Model 6 (full model) will be adjusted for all variables. Besides, sub-group analyses will be conducted among HIV-seroconcordant and-discordant couples. All the analyses will be conducted on both per-protocol and intention-to-treat basis. Per-protocol analysis will assess the efficacy of the intervention while intention-to-treat analysis will test its effectiveness . Attrition rates and reasons for dropout will be compared between the intervention and the control group . The significance level will be set at 5%. STATA version 13.1 will be used for all data analyses.