Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial.

BACKGROUND: Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda. METHODS: This is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone. DISCUSSION: This intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples' counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202102794681952 . Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021.

Assessing changes in knowledge, attitudes, and intentions to use family planning after watching documentary and drama health education films: a qualitative study.

BACKGROUND: There is a paucity of literature on the effectiveness of drama or documentary films in changing knowledge, beliefs, attitudes, and behavior of people towards family planning. This study aimed to compare and assess the acceptability of health promotion films based on documentary or drama, and their effect on knowledge, attitudes, and intention to use family planning. METHODS: We developed short documentary and drama films about contraceptive implants, using the person-based approach. Their acceptability was assessed in focus group discussions with younger women below 23 years, women over 23 years, men of reproductive age, and health workers in four different areas of Uganda (Bwindi/Kanungu, Walukuba/Jinja, Kampala, and Mbarara). Transcripts of the focus group discussions were analyzed using thematic analysis, to generate themes and examine the key issues. We assessed changes in knowledge, attitudes, and intentions to use family planning after watching the films. RESULTS: Sixteen focus groups with 150 participants were carried out. Participants said that the documentary improved their knowledge and addressed their fears about side effects, myths, and implant insertion. The drama improved their attitudes towards the implant and encouraged them to discuss family planning with their partner. The final versions of the documentary and the drama films were equally liked. CONCLUSIONS: Viewing a short documentary on the contraceptive implant led to positive changes in knowledge, while a short drama improved attitudes and intentions to discuss the implant with their partner. The drama and documentary have complementary features, and most participants wanted to see both.

Thousands of women and children in Uganda die every year due to problems related to pregnancy and childbirth. About 20% of these deaths are avoidable by better use of contraception. Many women are reluctant to begin contraception because of fears and myths about side-effects, and because they need the agreement of their husbands. The aim of this research was to study whether health education films could address these fears, and to compare a short documentary with a short drama film. We produced two health education films (a documentary and a drama) in two local languages with the involvement of local people. Films aimed to (1) dispel some myths on contraception, (2) encourage men to attend at least one antenatal clinic with their wives, and (3) discuss with a health worker whether they would like a method of family planning after the delivery. We showed these films to focus groups of local women, men and health workers in four contrasting areas of Uganda. The people taking part in the focus groups discussed their reactions to the films, whether they had learned anything from them, whether their attitudes towards family planning had changed as a result, and whether they intended to discuss this with their partner. Viewing a short documentary on the contraceptive implant improved knowledge, and short drama films improved attitudes and intentions to discuss the implant with their partner. The documentary and drama had different advantages, and most participants wanted to see both.

"The research assistants kept coming to follow me up; I counted myself as a lucky person": Social support arising from a longitudinal HIV cohort study in Uganda.

BACKGROUND: Participation in longitudinal research studies in resource-limited settings often involves frequent interactions with study staff and other participants, as well as receipt of incentives and transportation reimbursements. Social support-receipt of material and emotional resources from one's social network-has been linked to antiretroviral adherence in sub-Saharan Africa. The extent to which social support arises from study participation, its range and depth, and its implications for observational study conduct, have not been extensively described. METHODS: We conducted individual open-ended and semi-structured interviews with participants in a longitudinal, observational antiretroviral therapy adherence monitoring study in Mbarara, Uganda. Participants were asked about their experiences in the longitudinal study and their interactions with research staff. We also interviewed study research assistants (RAs). Deductive and inductive coding were used to identify content related to the experience of study participation. Codes were organized into themes, and relationships between themes were used to develop overarching categories. RESULTS: Sixty longitudinal study participants and 6 RAs were interviewed. Instrumental and emotional social support emerged as pervasive and valued aspects of longitudinal study participation. Instrumental support that participants received consisted of enhanced linkage to medical care, health education, and direct and indirect material benefits. Emotional support consisted of perceptions of feeling "cared for" and social interactions that permitted escape from HIV-related stigma. Both instrumental and emotional support often arose through the close relationships participants formed with research staff and with each other. Study-derived social support motivated some participants to adhere to antiretroviral therapy-an unanticipated effect potentially influencing the longitudinal study's primary observational outcome. CONCLUSIONS: Longitudinal study participation resulted in instrumental and emotional social support for participants. The depth of support participants experienced has implications for observational study design in resource-limited settings, including need to assess potential effects on study outcomes; consideration of social support during risk/benefit assessment in study ethics review and consent; and vigilance for consequences of social support loss when studies end.

Correction to: Ugandan Study Participants Experience Electronic Monitoring of Antiretroviral Therapy Adherence as Welcomed Pressure to Adhere.

The original version of this article unfortunately contained an error. The authors would like to correct the error with this erratum.

The importance of how research participants think they are perceived: results from an electronic monitoring study of antiretroviral therapy in Uganda.

Novel monitoring technologies in HIV research, such as electronic adherence monitors (EAMs), have changed the nature of researcher-participant interactions. Yet little is known about how EAMs and the resulting interaction between researchers and participants affect research participation and the data gathered. We interviewed participants and research assistants (RAs) in an observational cohort study involving EAMs for HIV antiretroviral therapy (ART) in Uganda. We qualitatively explored interviewees' views about ethical issues surrounding EAMs and assessed data with conventional and directed content analysis. Participants valued their relationships with RAs and were preoccupied with RAs' perceptions of them. Participants were pleased when the EAM revealed regular adherence, and annoyed when it revealed non-adherence that contradicted self-reported pill-taking behavior. For many, the desire to maintain a good impression incentivized adherence. But some sought to creatively conceal non-adherence, or refused to use the EAM to avoid revealing non-adherence to RAs. These findings show that participants' perceptions of the study staff's perceptions of them affected the experience of being monitored, study participation, and ultimately the data gathered in the study. Investigators in monitoring-based research should be aware that social interactions between participants and study staff could affect both the practical and ethical conduct of that research.

Ugandan Study Participants Experience Electronic Monitoring of Antiretroviral Therapy Adherence as Welcomed Pressure to Adhere.

Many new technologies monitor patients' and study participants' medical adherence. Some have cautioned that these devices transgress personal autonomy and ethics. But do they? This qualitative study explored how Ugandan study participants perceive the effect of electronic monitoring of their adherence to antiretroviral therapy (ART) on their freedoms to be non-adherent and pursue other activities that monitoring may inadvertently expose. Between August 2014 and June 2015, we interviewed 60 Ugandans living with HIV and enrolled in the Uganda AIDS Rural Treatment Outcomes (UARTO) study, a longitudinal, observational study involving electronic adherence monitors (EAMs) to assess ART adherence. We also interviewed 6 UARTO research assistants. Both direct and indirect content analysis were used to interpret interview transcripts. We found that monitoring created a sense of pressure to adhere to ART, which some participants described as "forcing" them to adhere. However, even participants who felt that monitoring forced them to take medications perceived using the EAM as conducive to their fundamental goal of high ART adherence. Overall, even if monitoring may have limited participants' effective freedom to be non-adherent, participants welcomed any such effect. No participant rejected the EAM on the grounds that it would limit that effective freedom. Reports that monitoring altered behaviors unrelated to pill-taking were rare. Researchers should continue to be vigilant about the ways in which behavioral health monitoring affects autonomy, but should also recognize that even autonomy-limiting monitoring strategies may enable participants to achieve their own goals.