HPTN024 IMPACT OF CLOSURE ON THE COMMUNITY

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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.

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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 51

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PROGRESS AT STOP OF ENROLLMENT IN LUSAKA

• Total enrolled 770 participants
• 647 HIV
• 123 HIV-
• OVER 85 in active follow-up
• 3 Study Clinics

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PRELIMINARY STUDY RESULTS ANNOUNCED IN DC AT FEB
HPTN MEETING

• Based on Data obtained by SCHARP and DSMB as at
  20th Dec. 2002
• 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

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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
  LD

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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.

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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

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RESULTSPERCEPTION 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

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RESULTSCOMMUNITY 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

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RESULTSRECOMMENDATIONS 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

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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

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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