HPTN024 IMPACT OF CLOSURE ON THE COMMUNITY MOSES SINKALA, DARA POTTER, MACLEAN UKWIMI, INONGE HATIMBULA, DOCTOR NGULUBE, VIOLET DAKA, ROBSTER MPUBULA,MAVIS NKHOMA, FRESHER MAPHIRI.

BACKGROUND The role of anti-biotic therapy in acute and chronic Chorioamnionitis for the prevention of chorio-amnionitis related transmission of HIV from infected mothers to infants. Phase III Double blind placebo controlled study design Multi- center: Dar-esalaam, Lilongwe, Blantyre and Lusaka 3200 HIV+ CLIENTS earmarked for recruitment in addition to HIV- in ratio of 5:1

PROGRESS AT STOP OF ENROLLMENT IN LUSAKA Total enrolled 770 participants –647 HIV+ –123 HIV- –OVER 85% in active follow-up 3 Study Clinics

PRELIMINARY STUDY RESULTS ANNOUNCED IN DC AT FEB HPTN MEETING Based on Data obtained by SCHARP and DSMB as at 20 th Dec –1/3 to Half of data available up to 6 weeks of FU No safety concerns were noted Study antibiotics (Ampicillin, Erythromycin and Metronidazole) did not add any value to NVP in the reduction of perinatal HIV transmission

RECOMMENDATION BY ROC NVP VERY EFFECTIVE IN PMTC NVP and Multivitamins to continue being dispensed to study participants as per study protocol The antibiotics, though not effective in PMTCT are still very useful in the treatment of other infections Continue follow-up of participants and the good clinical practices STOP any new Enrollments Inform all study participants, EC and the community about the preliminary results Make arrangements to withdraw antibiotics from participants still waiting to start the dose for L&D

INITIAL REACTION BY CAB AND STUDY STAFF Disappointments –Indication of lack of clear understanding of purpose of study –Job insecurity by staff Fear to explain to community –Strongly felt that community will misunderstand and loose trust in Research –Community likely to lose confidence in CAB Members and the health workers.

FURTHER EVALUATION ON THE IMPACT OF CLOSURE Application of self administered questionnaire to randomly selected nurses –Perceived community understanding –Perceptions on future impact of research Focus group discussion with the community –Knowledge about closure –Effect on Confidence in MCH/clinic services –Possibility of participants quitting the study –Effects on future research interventions –Recommendation for future research intervention

RESULTS:PERCEPTION BY NURSES [SS= 14] 30% of the nurses felt that the community understood very well why the recruitment of study participants was stopped 64% perceived that the community did not fully understand the issues for stopping the recruitment in spite of several attempts made to explain 6% could not commit themselves to any of the two alternatives Generally almost all the nurses felt that the community might have negative attitude towards future interventions

RESULTS:COMMUNITY PERCEPTIONS Almost all study participants who participated in FGD claimed that they were not adequately informed about the reasons for stoppage of the study –90% of participants said that the study was stopped because the number required for the study analysis had been reached Except for one client who had an appointment for enrolment all participants felt that they will be willing to participate in future research interventions One of the major complaint was lack of equity by nurses to attend to their physical ailments during inter-current visits Participants strongly felt that the recruitment of the study participants should have continued in spite of facilitators of FGD giving adequate explanation for stoppage of study –This is because many participants felt that the study had many benefits

RESULTS:RECOMMENDATIONS BY THE COMMUNITY Before phasing out a research with visible benefits investigators should ensure that another similar intervention is introduced If a research is dealing with mothers or women there should be ways for husbands or partners to benefit as well Community education should continue for a reasonable period of time until the community come to understand why a study has been stopped Interaction of health workers and community educators should be strengthened in spite of the study being stopped –This will avoid unnecessary destructive rumors

CONCLUSIONS- 1 Before a study is implemented there should be deliberate measures to explain the research to the general community especially in the targeted area Strengthening the training of CAB members and staff involved in recruiting study participants in the process of the informed consent Before a large number of study participants are recruited/enrolled investigators and CAB members must ensure that clients have understood the informed consent and the purpose of the study –This may require regular INTERNAL random monitoring and evaluation by a team composed of investigators and CAB members

CONCLUSIONS- 2 Strengthening GCP training for study staff at regular intervals Ensure adequate training of support staff and research assistants in research protocols and SOPS Ensure availability of adequate resources to: –Hire qualified motivated staff –Improve good clinical practices including physical infrastructure where it is needed –Adequate allocation of resources for follow up including motivation of the community members assisting in FP Evaluation is still ongoing- More conclusive findings being awaited