Standardization of intervention delivery in accordance with the principles of the disclosure intervention is achieved by use of a manualized intervention protocol. The ADDS received training until mastery of the protocol was demonstrated. As part of the content validation, the ADDS maintains a log of each contact that details date, length of visit, whether full intervention protocol was completed, content of visit discussion and difficulties encountered and strategies used to manage them. Participant exposure to the intervention is quantified both in terms of the number of contacts and time spent in each contact.
Control group – usual care
Participants in the control arm receive usual clinic care wherein the provider assesses the caregiver's disclosure readiness, but typically does not discuss disclosure unless impelled by queries of the caregiver or child. To prevent the rate of disclosure at the intervention site being confounded by the time/attention of the ADDS, an attention control ADDS is employed. This individual meets with the caregivers and provides general health information (e.g. medication adherence) and answers questions the caregivers may have. Given that our disclosure intervention has not demonstrated feasibility and efficacy, the trial design meets equipoise. If the intervention is successful, we plan to collaborate with the National AIDS Control Programme to scale it up nationally.
Data are collected at baseline and follow-up with standardized instruments (summarized in Table 3) [31–41] that were selected in accordance with our guiding conceptual model and prior studies [16,42]. The primary outcome is the proportion of caregiver disclosure of paediatric HIV at 1-year follow-up. Other outcomes of interest are information, motivation and behavioural skills of the participants, health outcomes (medication adherence, viral and immunologic markers, mental health parameters) and fidelity and acceptability of the disclosure intervention.
A web-accessible and interactive database system, developed at Purdue University, is used for the acquisition, storage and exploration of and other study data. The system is built on top of the HUBzero cyber infrastructure (http://hubzero.org), which uses web-based data technology components to create a secure and private (compliant with HIPPA regulations), customized database. The interactive nature of the database is illustrated in Fig. 3 and described fully elsewhere .
Statistical analyses will be conducted on an intention-to-treat sample. Where appropriate, hypotheses will be tested by independent statistical analyses using mixed models procedures to test for the effect of group assignment (intervention vs. control), time and the interaction between assignment and time. Analysis will be carried out to account for different impact on different age groups. Possible correlation between individuals within each of the two sites will be assessed during analysis by taking into account the intracluster correlation coefficient. Interval-censored survival analysis techniques will be used to analyse the primary outcome. In addition, the proportion of participants with disclosure will be compared between the two study arms using Chi-square methods.
Progress to date
A team of bi-national (Ghanaian, U.S./Ghanaian and U.S.), multidisciplinary investigators with complementary individual and collective expertise were assembled for development and execution of the trial. The investigators at the participating institutions have worked together closely on implementation of the project. The project was launched with an intensive, 3-day face-to-face team meeting held at a location off-site in Ghana. The meeting focused on training in all aspects of the study procedures and building collaborative team relationships and patterns of open communication, an important consideration among team members with different disciplinary backgrounds, culturally informed assumptions and patterns of communication that could be constrained by hierarchical norms. This was followed by weekly Skype calls with the U.S. and Ghanaian investigators and project coordinators, monthly Skype calls with the full team and intermittent Skype and e-mail communication carried out on an ‘as needed’ basis. In addition, one of the U.S. investigators meets with the Ghanaian investigators in Ghana at least quarterly and follow-up face-to-face meetings are held with the full team annually.
Critical to the success of the project to date have been the two dedicated on-site project coordinators (one full time at each site), development of a close working relationship among team members and regular, open communication that has facilitated prompt action when needed and monitoring of project data in ‘real-time’ with use of the web-accessible database system.
Participant baseline characteristics
Nearly one-half of the target caregiver–child dyads have been enrolled (from January 2013 to July 2014). Sixty-six percent (N = 298) of the caregiver/child dyads screened (N = 451) have been enrolled to the study. Refusal of the caregiver or child has accounted for 15% of caregiver/child dyads who were not enrolled to the study. Enrolment and characteristics of the participants have been comparable at the two sites (see Table 4). The mean age of the caregivers is 41 years, roughly 60% are HIV positive and 80% are female. The children are 50% female with a mean age of 10 years. No adverse events have been reported to date, even among participants who have elected to disclose while enrolled in the study.
Among the challenges encountered thus far are factors that have had an unexpected influence on the participating clinic operations including a lengthy physician strike and irregularity of paediatric antiretroviral medications available for distribution at the participating sites. Shortages of CD4+ reagents and viral load tests kits have also been challenging as has the unexpected change in some of the children's caregivers during the course of the study follow-up.
It was anticipated that some participants, given low levels of education, would have difficulty completing the self-report study questionnaires independently. This is handled by collecting the data orally in face-to-face interviews. However, a related, unanticipated issue has been the difficulty some participants have rendering responses in scales with a graded response format (e.g. 1–7 Likert-type scales). In order to facilitate an understanding of the meaning of the numeric gradations, the interviewers have developed a culturally familiar, pictorial aid, such as food baskets filled to different levels, to signify amount of agreement with the questionnaire statement.
Despite compelling evidence supporting the merits of informing children of their HIV status, disclosure of HIV to infected children is lagging. Little emphasis has been placed on equipping the child's caregiver with information and skills to promote disclosure, particularly, when the caregiver faces a variety of sociocultural barriers and is reluctant to do so. The purpose of this ongoing project is to provide information on the efficacy of a structured disclosure intervention that can be integrated into usual care in resource-limited settings to facilitate the engagement of caregivers in the process of disclosure in a socioculturally, developmentally appropriate manner.
The project builds on our preliminary and ongoing work in Ghana and the complementary expertise of the team; together, they provide a socioculturally contextualized understanding of the problem and inform the content and structure of the disclosure intervention that is being tested. Our preliminary work shows a variety of sociocultural contextual barriers and deficient skills drive the persistent reluctance of caregivers and healthcare providers to inform children of their diagnosis. We propose that several key factors may be modified and the process of disclosure promoted with an intervention approach that is grounded in behavioural and bioecological systems theory.
The project is progressing well with nearly half of the target caregiver–child dyads enrolled to date. Success may be attributed to a number of factors, including the strength of the working relationships between the bi-national team, the web-accessible database system and the interest and engagement of participants in the project.
Implementation has not been without challenges. One unanticipated issue of note to date is our use of standardized Likert-type self-report measures in a population with lower numeric literacy than the population in which the measures were originally developed and tested. The literature is replete with information on methods for the cross-cultural adaptation of self-report questionnaires for use in a new country, culture and/or language in order to reach equivalence between the original source and target setting [44–46]. However, little attention has been given to methods to reduce error associated with numerical literacy [47–50]. In this study, we elected to retain the established response anchors of the standardized measures, but use a pictorial aid to enhance comprehension. We acknowledge the potential limitations of this approach and think that it is an important area for further study.
Randomization by site is advantageous in that it allows us to control for contamination across individuals within the study sites. However, this design introduces the potential for baseline differences between treatment and control groups and correlation between individuals within each site. When comparing differences in outcomes achieved, we must account for the fact that two participants sampled from a single site are more likely to be similar (in terms of outcomes) than two participants sampled from different sites. Compared with trial designs in which individuals are randomized, the SANKOFA trial design introduces greater complexity as nonindependence must be assessed and corrected analytically as indicated.
Generalizability of the study may be limited by a few factors. The sites selected for conduct of the study offer the advantage of an infrastructure to support conduct of the study with rigor. It is acknowledged that the level of clinical research expertise available at these sites may not be representative of other HIV treatment centres in Ghana, but resources important for the delivery of the intervention are likely to be available at most sites. The intervention is delivered by a clinic staff member and designated as the site ‘disclosure specialist’. This approach was selected because it was thought to be both practical and a potentially effective, sustainable model. The clinic staff member is knowledgeable of local sociocultural norms and the challenges of living with HIV. In the role as ‘disclosure specialist’, the clinic staff member becomes the ‘point person’ and agent for change over time. It is possible that this specialist approach could limit generalizability of the intervention to other sites with more limited resources. This warrants further examination. Findings from this study should provide some insight, as we are assessing the total amount of time the specialist spends in delivery of the intervention and other aspects of feasibility.
In conclusion, the low prevalence of disclosure underscores the need for a systematic and a staged approach in disclosing HIV status to infected children in resource-limited countries. Findings from this study will show whether a culturally relevant, standardized disclosure intervention that can be integrated into routine clinical paediatric HIV care can improve the welfare of children and their caregivers in Ghana. Results from this project will also contribute to a better understanding of factors and processes driving paediatric HIV disclosure as well as methods for use in future studies.
We thank the Sankofa Project caregiver and child dyads for their participation. We are grateful to the staff at Pediatric AIDS Clinics at Korle-Bu and Komfo Anokye Teaching Hospitals and the Ghana–Yale Partnership for Global Health for their support. We would also like to acknowledge the full roster of study team members by site: Elijah Paintsil, Nancy Reynolds, Tassos Kyriakides, Xiangyu Cong and Yram Foli, Yale University, USA; Lorna Renner, Margaret Lartey, Angela Ofori-Atta, Jonas Kusah Tetteh, Joyceline Assimeng, Obedia Akweley Seaneke, Dramani Yakubu, and Kevin Bonsu, Korle-Bu Teaching Hospital, Accra, Ghana; Sampson Antwi, Kofi Aikins Amissah, Anthony Enimil, Amina Alhassan and Irene Pokuaa Ofori, Komfo Anokye Teaching Hospital, Kumasi, Ghana; Ann Christine Catlin, Sumudinie Fernando, Ruwan Egoda Gamage, Ruchith Fernando and Sudheera Fernando, Purdue University, USA.
This study was made possible by a grant from NIH/NICHD (R01HD074253). The content of the study is solely the responsibility of the authors and does not necessarily represent the official view of NIH.
Nancy Reynolds did the conception and design of the work, analysis and interpretation of data, drafting manuscript.
Angela Ofori-Atta and Tassos Kyriakides did the conception and design of the work, analysis and interpretation of data, revising manuscript for important intellectual content.
Margaret Lartey and Sampson Antwi did the conception and design of the work, interpretation of data, revising manuscript for important intellectual content.
Anthony Enimil did the acquisition and interpretation of data, revising manuscript for important intellectual content.
Ann Christine Catlin did the conception and design of the work, drafting and revising manuscript for important intellectual content.
Sumudinie Fernando did the conception and design of the work, revising manuscript for important intellectual content.
Elijah Paintsil did the conception and design of the work, analysis and interpretation of data, drafting and revising manuscript for important intellectual content.
All authors gave final approval of this version and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding for this study was provided by National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health & Human Development (R01 HD074252).
ClinicalTrials.gov Identifier: NCT01701635.
Conflicts of interest
There are no conflicts of interest.
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Keywords:Copyright © 2015 Wolters Kluwer Health, Inc.
clinical trial; disclosure; Ghana; HIV; intervention; paediatric